Pixel array medical systems, devices and methods

ABSTRACT

Systems, instruments, and methods are described in which a scalpet device comprises a housing configured to include a scalpet assembly. The scalpet assembly includes a scalpet array and one or more guide plates. The scalpet array includes a set of scalpets, and in embodiments the set of scalpets include multiple scalpets. The guide plate maintains a configuration of the set of scalpets. The set of scalpets is configured to be deployed from and retracted into the housing, and is configured to generate incised skin pixels at a target site when deployed. The incised skin pixels are harvested.

RELATED APPLICATIONS

This application claims the benefit of U.S. Patent Application No.62/112,350, filed Feb. 5, 2015.

This application claims the benefit of U.S. Patent Application No.62/139,180, filed Mar. 27, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,274, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,284, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,267, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,290, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/840,307, filed Aug. 31, 2015.

This application is a continuation in part of U.S. patent applicationSer. No. 14/505,090, filed Oct. 2, 2014.

This application is a continuation in part of U.S. patent applicationSer. No. 14/505,183, filed Oct. 2, 2014.

This application is a continuation in part of U.S. patent applicationSer. No. 14/099,380, filed Dec. 6, 2013.

This application is a continuation in part of U.S. patent applicationSer. No. 14/556,648, filed Dec. 1, 2014, which is a continuation of U.S.patent application Ser. No. 12/972,013, filed Dec. 17, 2010, now U.S.Pat. No. 8,900,181.

TECHNICAL FIELD

The embodiments herein relate to medical systems, instruments ordevices, and methods and, more particularly, to medical instrumentationand methods applied to the surgical management of burns, skin defects,and hair transplantation.

BACKGROUND

The aging process is most visibly depicted by the development ofdependent skin laxity. This life long process may become evident asearly as the third decade of life and will progressively worsen oversubsequent decades. Histological research has shown that dependantstretching or age related laxity of the skin is due in part toprogressive dermal atrophy associated with a reduction of skin tensilestrength. When combined with the downward force of gravity, age relateddermal atrophy will result in the two dimensional expansion of the skinenvelope. The clinical manifestation of this physical-histologicalprocess is redundant skin laxity. The most affected areas are the headand neck, upper arms, thighs, breasts, lower abdomen and knee regions.The most visible of all areas are the head and neck. In this region,prominent “turkey gobbler” laxity of neck and “jowls” of the lower faceare due to an unaesthetic dependency of skin in these areas.

Plastic surgery procedures have been developed to resect the redundantlax skin. These procedures must employ long incisions that are typicallyhidden around anatomical boundaries such as the ear and scalp for afacelift and the inframammary fold for a breast uplift (mastopexy).However, some areas of skin laxity resection are a poor tradeoff betweenthe aesthetic enhancement of tighter skin and the visibility of thesurgical incision. For this reason, skin redundancies of the upper arm,suprapatellar knees, thighs and buttocks are not routinely resected dueto the visibility of the surgical scar.

The frequency and negative societal impact of this aesthetic deformityhas prompted the development of the “Face Lift” surgical procedure.Other related plastic surgical procedures in different regions are theAbdominoplasty (Abdomen), the Mastopexy (Breasts), and the Brachioplasty(Upper Arms). Inherent adverse features of these surgical procedures arepost-operative pain, scarring and the risk of surgical complications.Even though the aesthetic enhancement of these procedures is anacceptable tradeoff to the significant surgical incisions required,extensive permanent scarring is always an incumbent part of theseprocedures. For this reason, plastic surgeons design these procedures tohide the extensive scarring around anatomical borders such as thehairline (Facelift), the inframmary fold (Mastopexy), and the inguinalcrease (Abdominoplasty). However, many of these incisions are hiddendistant to the region of skin laxity, thereby limiting theireffectiveness. Other skin laxity regions such as the Suprapatellar(upper-front) knee are not amendable to plastic surgical resections dueto the poor tradeoff with a more visible surgical scar.

More recently, electromagnetic medical devices that create a reversethermal gradient (i.e., Thermage) have attempted with variable successto tighten skin without surgery. At this time, these electromagneticdevices are best deployed in patients with a moderate amount of skinlaxity. Because of the limitations of electromagnetic devices andpotential side effects of surgery, a minimally invasive technology isneeded to circumvent surgically related scarring and the clinicalvariability of electromagnetic heating of the skin. For many patientswho have age related skin laxity (neck and face, arms, axillas, thighs,knees, buttocks, abdomen, bra line, ptosis of the breast), fractionalresection of excess skin could augment a significant segment oftraditional plastic surgery.

Even more significant than aesthetic modification of the skin envelopeis the surgical management of burns and other trauma related skindefects. Significant burns are classified by the total body surfaceburned and by the depth of thermal destruction. First-degree andsecond-degree burns are generally managed in a non-surgical fashion withthe application of topical creams and burn dressings. Deeperthird-degree burns involve the full thickness thermal destruction of theskin. The surgical management of these serious injuries involves thedebridement of the burn eschar and the application of split thicknessgrafts.

Any full thickness skin defect, most frequently created from burning,trauma, or the resection of a skin malignancy, can be closed with eitherskin flap transfers or skin grafts using current commercialinstrumentation. Both surgical approaches require harvesting from adonor site. The use of a skin flap is further limited by the need of toinclude a pedicle blood supply and in most cases by the need to directlyclose the donor site.

The split thickness skin graft procedure, due to immunologicalconstraints, requires the harvesting of autologous skin grafts, that is,from the same patient. Typically, the donor site on the burn patient ischosen in a non-burned area and a partial thickness sheet of skin isharvested from that area. Incumbent upon this procedure is the creationof a partial thickness skin defect at the donor site. This donor sitedefect is itself similar to a deep second-degree burn. Healing byre-epithelialization of this site is often painful and may be prolongedfor several days. In addition, a visible donor site deformity is createdthat is permanently thinner and more de-pigmented than the surroundingskin. For patients who have burns over a significant surface area, theextensive harvesting of skin grafts may also be limited by theavailability of non-burned areas.

For these reasons, there is a need in the rapidly expanding aestheticmarket for instrumentation and procedures for aesthetic surgical skintightening. There is also a need for systems, instruments or devices,and procedures that enable the repeated harvesting of skin grafts fromthe same donor site while eliminating donor site deformity.

INCORPORATION BY REFERENCE

Each patent, patent application, and/or publication mentioned in thisspecification is herein incorporated by reference in its entirety to thesame extent as if each individual patent, patent application, and/orpublication was specifically and individually indicated to beincorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the PAD Kit placed at a target site, under an embodiment.

FIG. 2 is a cross-section of a scalpet punch or device including ascalpet array, under an embodiment.

FIG. 3 is a partial cross-section of a scalpet punch or device includinga scalpet array, under an embodiment.

FIG. 4 shows the adhesive membrane with backing (adherent substrate)included in a PAD Kit, under an embodiment.

FIG. 5 shows the adhesive membrane (adherent substrate) when used withthe PAD Kit frame and blade assembly, under an embodiment.

FIG. 6 shows the removal of skin pixels, under an embodiment.

FIG. 7 is a side view of blade transection and removal of incised skinpixels with the PAD Kit, under an embodiment.

FIG. 8 is an isometric view of blade/pixel interaction during aprocedure using the PAD Kit, under an embodiment.

FIG. 9 is another view during a procedure using the PAD Kit (bladeremoved for clarity) showing both harvested skin pixels or plugstransected and captured and non-transected skin pixels or plugs prior totransection, under an embodiment.

FIG. 10A is a side view of a portion of the pixel array showing scalpetssecured onto an investing plate, under an embodiment.

FIG. 10B is a side view of a portion of the pixel array showing scalpetssecured onto an investing plate, under an alternative embodiment.

FIG. 10C is a top view of the scalpet plate, under an embodiment.

FIG. 10D is a close view of a portion of the scalpet plate, under anembodiment.

FIG. 11A shows an example of rolling pixel drum, under an embodiment.

FIG. 11B shows an example of a rolling pixel drum assembled on a handle,under an embodiment.

FIG. 11C depicts a drum dermatome for use with the scalpet plate, underan embodiment.

FIG. 12A shows the drum dermatome positioned over the scalpet plate,under an embodiment.

FIG. 12B is an alternative view of the drum dermatome positioned overthe scalpet plate, under an embodiment.

FIG. 13A is an isometric view of application of the drum dermatome(e.g., Padgett dermatome) over the scalpet plate, where the adhesivemembrane is applied to the drum of the dermatome before rolling it overthe investing plate, under an embodiment.

FIG. 13B is a side view of a portion of the drum dermatome showing ablade position relative to the scalpet plate, under an embodiment.

FIG. 13C is a side view of the portion of the drum dermatome showing adifferent blade position relative to the scalpet plate, under anembodiment.

FIG. 13D is a side view of the drum dermatome with another bladeposition relative to the scalpet plate, under an embodiment.

FIG. 13E is a side view of the drum dermatome with the transection bladeclip showing transection of skin pixels by the blade clip, under anembodiment.

FIG. 13F is a bottom view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 13G is a front view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 13H is a back view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 14A shows an assembled view of the dermatome with the Pixel OnlaySleeve (POS), under an embodiment.

FIG. 14B is an exploded view of the dermatome with the Pixel OnlaySleeve (POS), under an embodiment.

FIG. 14C shows a portion of the dermatome with the Pixel Onlay Sleeve(POS), under an embodiment.

FIG. 15A shows the Slip-On PAD being slid onto a Padgett Drum Dermatome,under an embodiment.

FIG. 15B shows an assembled view of the Slip-On PAD installed over thePadgett Drum Dermatome, under an embodiment.

FIG. 16A shows the Slip-On PAD installed over a Padgett Drum Dermatomeand used with a perforated template or guide plate, under an embodiment.

FIG. 16B shows skin pixel harvesting with a Padgett Drum Dermatome andinstalled Slip-On PAD, under an embodiment.

FIG. 17A shows an example of a Pixel Drum Dermatome being applied to atarget site of the skin surface, under an embodiment.

FIG. 17B shows an alternative view of a portion of the Pixel DrumDermatome being applied to a target site of the skin surface, under anembodiment.

FIG. 18 shows a side perspective view of the PAD assembly, under anembodiment.

FIG. 19A shows a top perspective view of the scalpet device for use withthe PAD assembly, under an embodiment.

FIG. 19B shows a bottom perspective view of the scalpet device for usewith the PAD assembly, under an embodiment.

FIG. 20 shows a side view of the punch impact device including a vacuumcomponent, under an embodiment.

FIG. 21A shows a top view of an oscillating flat scalpet array and bladedevice, under an embodiment.

FIG. 21B shows a bottom view of an oscillating flat scalpet array andblade device, under an embodiment.

FIG. 21C is a close-up view of the flat array when the array ofscalpets, blades, adherent membrane and the adhesive backer areassembled together, under an embodiment.

FIG. 21D is a close-up view of the flat array of scalpets with a feedercomponent, under an embodiment.

FIG. 22 shows a cadaver dermal matrix cylindrically transected similarin size to the harvested skin pixel grafts, under an embodiment.

FIG. 23 is a drum array drug delivery device, under an embodiment.

FIG. 24A is a side view of a needle array drug delivery device, under anembodiment.

FIG. 24B is an upper isometric view of a needle array drug deliverydevice, under an embodiment.

FIG. 24C is a lower isometric view of a needle array drug deliverydevice, under an embodiment.

FIG. 25 shows the composition of human skin.

FIG. 26 shows the physiological cycles of hair growth.

FIG. 27 shows harvesting of donor follicles, under an embodiment.

FIG. 28 shows preparation of the recipient site, under an embodiment.

FIG. 29 shows placement of the harvested hair plugs at the recipientsite, under an embodiment.

FIG. 30 shows placement of the perforated plate on the occipital scalpdonor site, under an embodiment.

FIG. 31 shows scalpet penetration depth through skin when the scalpet isconfigured to penetrate to the subcutaneous fat layer to capture thehair follicle, under an embodiment.

FIG. 32 shows hair plug harvesting using the perforated plate at theoccipital donor site, under an embodiment.

FIG. 33 shows creation of the visible hairline, under an embodiment.

FIG. 34 shows preparation of the donor site using the patternedperforated plate and spring-loaded pixilation device to create identicalskin defects at the recipient site, under an embodiment.

FIG. 35 shows transplantation of harvested plugs by inserting harvestedplugs into a corresponding skin defect created at the recipient site,under an embodiment.

FIG. 36 shows a clinical end point using the pixel dermatomeinstrumentation and procedure, under an embodiment.

FIG. 37 is an image of the skin tattooed at the corners and midpoints ofthe area to be resected, under an embodiment.

FIG. 38 is an image of the post-operative skin resection field, under anembodiment.

FIG. 39 is an image at 11 days following the procedure showingresections healed per primam, with measured margins, under anembodiment.

FIG. 40 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured margins, under an embodiment.

FIG. 41 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured lateral dimensions, under anembodiment.

FIG. 42 is an image at 90 days post-operative showing resections healedper primam and maturation of the resection field continuing per primam,with measured lateral dimensions, under an embodiment.

FIG. 43 is a scalpet showing the applied rotational and/or impactforces, under an embodiment.

FIG. 44 shows a geared scalpet and an array including geared scalpets,under an embodiment.

FIG. 45 is a bottom perspective view of a resection device including thescalpet assembly with geared scalpet array, under an embodiment.

FIG. 46 is a bottom perspective view of the scalpet assembly with gearedscalpet array (housing not shown), under an embodiment.

FIG. 47 is a detailed view of the geared scalpet array, under anembodiment.

FIG. 48 shows an array including scalpets in a frictional driveconfiguration, under an embodiment.

FIG. 49 shows a helical scalpet (external) and an array includinghelical scalpets (external), under an embodiment.

FIG. 50 shows side perspective views of a scalpet assembly including ahelical scalpet array (left), and the resection device including thescalpet assembly with helical scalpet array (right) (housing shown),under an embodiment.

FIG. 51 is a side view of a resection device including the scalpetassembly with helical scalpet array assembly (housing depicted astransparent for clarity of details), under an embodiment.

FIG. 52 is a bottom perspective view of a resection device including thescalpet assembly with helical scalpet array assembly (housing depictedas transparent for clarity of details), under an embodiment.

FIG. 53 is a top perspective view of a resection device including thescalpet assembly with helical scalpet array assembly (housing depictedas transparent for clarity of details), under an embodiment.

FIG. 54 is a push plate of the helical scalpet array, under anembodiment.

FIG. 55 shows the helical scalpet array with the push plate, under anembodiment.

FIG. 56 shows an inner helical scalpet and an array including innerhelical scalpets, under an embodiment.

FIG. 57 shows the helical scalpet array with the drive plate, under anembodiment.

FIG. 58 shows a slotted scalpet and an array including slotted scalpets,under an embodiment.

FIG. 59 shows a portion of a slotted scalpet array (e.g., four (4)scalpets) with the drive rod, under an embodiment.

FIG. 60 shows an example slotted scalpet array (e.g., 25 scalpets) withthe drive rod, under an embodiment.

FIG. 61 shows an oscillating pin drive assembly with a scalpet, under anembodiment.

FIG. 62 shows variable scalpet exposure control with the scalpet guideplates, under an embodiment.

FIG. 63 shows a scalpet assembly including a scalpet array (e.g.,helical) configured to be manually driven by an operator, under anembodiment.

FIG. 64 shows forces exerted on a scalpet via application to the ski.

FIG. 65 depicts steady axial force compression using a scalpet, under anembodiment.

FIG. 66 depicts steady single axial force compression plus kineticimpact force using a scalpet, under an embodiment.

FIG. 67 depicts moving of the scalpet at a velocity to impact and piercethe skin, under an embodiment.

FIG. 68 depicts a multi-needle tip, under an embodiment.

FIG. 69 shows a square scalpet without teeth (left), and a squarescalpet with multiple teeth (right), under an embodiment.

FIG. 70 shows multiple side, front (or back), and side perspective viewsof a round scalpet with an oblique tip, under an embodiment.

FIG. 71 shows a round scalpet with a serrated edge, under an embodiment.

FIG. 72 shows a side view of the resection device including the scalpetassembly with scalpet array and extrusion pins (housing depicted astransparent for clarity of details), under an embodiment.

FIG. 73 shows a top perspective cutaway view of the resection deviceincluding the scalpet assembly with scalpet array and extrusion pins(housing depicted as transparent for clarity of details), under anembodiment.

FIG. 74 shows side and top perspective views of the scalpet assemblyincluding the scalpet array and extrusion pins, under an embodiment.

FIG. 75 is a side view of a resection device including the scalpetassembly with scalpet array assembly coupled to a vibration source,under an embodiment.

FIG. 76 shows a scalpet array driven by an electromechanical source orscalpet array generator, under an embodiment.

FIG. 77 is a diagram of the resection device including a vacuum system,under an embodiment.

FIG. 78 shows a vacuum manifold applied to a target skin surface toevacuate/harvest excised skin/hair plugs, under an embodiment.

FIG. 79 shows a vacuum manifold with an integrated wire mesh applied toa target skin surface to evacuate/harvest excised skin/hair plugs, underan embodiment.

FIG. 80 shows a vacuum manifold with an integrated wire mesh configuredto vacuum subdermal fat, under an embodiment.

FIG. 81 depicts a collapsible docking station and an inserted skinpixel, under an embodiment. The docking station is formed fromelastomeric material but is not so limited.

FIG. 82 is a top view of a docking station (e.g., elastomeric) instretched (left) and un-stretched (right) configuration, under anembodiment, under an embodiment.

DETAILED DESCRIPTION

Systems, instruments, and methods are described in which a scalpetdevice comprises a housing configured to include a scalpet assembly. Thescalpet assembly includes a scalpet array and one or more guide plates.The scalpet array includes a set of scalpets, and in embodiments the setof scalpets include multiple scalpets. The guide plate maintains aconfiguration of the set of scalpets. The set of scalpets is configuredto be deployed from and retracted into the housing, and is configured togenerate incised skin pixels at a target site when deployed. The incisedskin pixels are harvested.

The scalpet device described herein satisfies the expanding aestheticmarket for instrumentation and procedures for aesthetic surgical skintightening. Additionally, the embodiments enable the repeated harvestingof skin grafts from the same donor site while eliminating donor sitedeformity. The embodiments described herein are configured to resectredundant lax skin without visible scarring so that all areas ofredundant skin laxity can be resected by the pixel array dermatome andprocedures may be performed in areas that were previously off limits dueto the visibility of the surgical incision. The technical effectsrealized through the embodiments described herein include smooth,tightened skin without visible scarring or long scars along anatomicalborders.

Embodiments described in detail herein, which include pixel skingrafting instrumentation and methods, are configured to provide thecapability to repeatedly harvest split thickness skin grafts withoutvisible scarring of the donor site. During the procedure, a Pixel ArrayDermatome (PAD) is used to harvest the skin graft from the chosen donorsite. During the harvesting procedure, a pixilated skin graft isdeposited onto a flexible, semi-porous, adherent membrane. The harvestedskin graft/membrane composite is then applied directly to the recipientskin defect site. The fractionally resected donor site is closed withthe application of an adherent sheeting or bandage (e.g., Flexzan®sheeting, etc.) that functions for a period of time (e.g., one week,etc.) as a large butterfly bandage. The intradermal skin defectsgenerated by the PAD are closed to promote a primary healing process inwhich the normal epidermal-dermal architecture is realigned in ananatomical fashion to minimize scarring. Also occurring postoperatively,the adherent membrane is desquamated (shed) with the stratum corneum ofthe graft; the membrane can then be removed without disruption of thegraft from the recipient bed.

Numerous effects realized by the pixel skin grafting procedure deserveexplanation. Because the skin graft is pixelated it provides intersticesfor drainage between skin plug components, which enhances the percentageof “takes,” compared to sheet skin grafts. During the firstpost-operative week, the skin graft “takes” at the recipient site by aprocess of neovascularization in which new vessels from the recipientbed of the skin defect grow into the new skin graft. The semiporousmembrane conducts the exudate into the dressing.

The flexible membrane is configured with an elastic recoil property thatpromotes apposition of component skin plugs within the graft/membranecomposite; promoting primary adjacent healing of the skin graft plugsand converting the pixilated appearance of the skin graft into a moreuniform sheet morphology. Furthermore, the membrane aligns themicro-architectural components skin plugs, so epidermis aligns withepidermis and dermis aligns with dermis, promoting a primary healingprocess that reduces scarring.

There are numerous major clinical applications for the dermatomesdescribed in detail herein, including fractional skin resection for skintightening, fractional hair grafting for alopecia, and fractional skinharvesting for skin grafting. Fractional skin resection of an embodimentcomprises harvesting skin plugs using an adherent membrane, however thefractionally incised skin plugs can be evacuated without harvesting. Theparadigm of incising, evacuating and closing is most descriptive of theclinical application of skin tightening. The embodiments describedherein are configured to facilitate incising and evacuating and, inorder to provide for a larger scalpet array with a greater number ofscalpets, the embodiments include a novel means of incising the skinsurface.

Pixel array medical systems, instruments or devices, and methods aredescribed for skin grafting and skin resection procedures, and hairtransplantation procedures. In the following description, numerousspecific details are introduced to provide a thorough understanding of,and enabling description for, embodiments herein. One skilled in therelevant art, however, will recognize that these embodiments can bepracticed without one or more of the specific details, or with othercomponents, systems, etc. In other instances, well-known structures oroperations are not shown, or are not described in detail, to avoidobscuring aspects of the disclosed embodiments.

The following terms are intended to have the following general meaningas they may be used herein. The terms are not however limited to themeanings stated herein as the meanings of any term can include othermeanings as understood or applied by one skilled in the art.

“First degree burn” as used herein includes a superficial thermal injuryin which there is no disruption of the epidermis from the dermis. Afirst-degree burn is visualized as erythema (redness) of the skin.

“Second degree burn” as used herein includes a relatively deeper burn inwhich there is disruption of the epidermis from the dermis and where avariable thickness of the dermis is also denatured. Most second-degreeburns are associated with blister formation. Deep second-degree burnsmay convert to full thickness third degree burns, usually by oxidationor infection.

“Third degree burn” as used herein includes a burn associated with thefull thickness thermal destruction of the skin including the epidermisand the dermis. A third degree burn may also be associated with thermaldestruction of deeper, underlying tissues (subcutaneous and musclelayers).

“Ablation” as used herein includes the removal of tissue by destructionof the tissue e.g., thermal ablation of a skin lesion by a laser.

“Autograft” as used herein includes a graft taken from the same patient.

“Backed Adherent Membrane” as used herein includes the elastic adherentmembrane that captures the transected skin plugs. The Backed AdherentMembrane of an embodiment is backed on the outer surface to retainalignment of the skin plugs during harvest. After harvesting of the skinplugs, the backing is removed from the adherent membrane with harvestedskin plugs. The membrane of an embodiment is porous to allow fordrainage when placed at the recipient site. The membrane of anembodiment also possesses an elastic recoil property, so that when thebacking is removed, it brings the sides of the skin plugs closer to eachother to promote healing at the recipient site as a sheet graft.

“Burn Scar Contraction” as used herein includes the tightening of scartissue that occurs during the wound healing process. This process ismore likely to occur with an untreated third degree burn.

“Burn Scar Contracture” as used herein includes a band of scar tissuethat either limits the range of motion of a joint or band of scar tissuethat distorts the appearance of the patient i.e., a burn scarcontracture of the face.

“Dermatome” as used herein includes an instrument that “cuts skin” orharvests a sheet split thickness skin graft. Examples of drum dermatomesinclude the Padgett and Reese dermatomes. Electrically powereddermatomes are the Zimmer dermatome and one electric version of thePadgett dermatome.

“Dermis” as used herein includes the deep layer of skin that is the mainstructural support and primarily comprises non-cellular collagen fibers.Fibroblasts are cells in the dermis that produce the collagen proteinfibers.

“Donor Site” as used herein includes the anatomical site from which askin graft is harvested.

“Epidermis” as used herein includes the outer layer of skin comprisingviable epidermal cells and nonviable stratum corneum that acts as abiological barrier.

“Excise” as used herein includes the surgical removal of tissue.

“Excisional Skin Defect” as used herein includes a partial thickness or,more typically, a full thickness defect that results from the surgicalremoval (excision/resection) of skin (lesion).

“FTSG” as used herein includes a Full Thickness Skin Graft in which theentire thickness of the skin is harvested. With the exception of aninstrument as described herein, the donor site is closed as a surgicalincision. For this reason, FTSG is limited in the surface area that canbe harvested.

“Granulation Tissue” as used herein includes highly vascularized tissuethat grows in response to the absence of skin in a full-thickness skindefect. Granulation Tissue is the ideal base for a skin graft recipientsite.

“Healing by primary intention” as used herein includes the wound healingprocess in which normal anatomical structures are realigned with aminimum of scar tissue formation. Morphologically the scar is lesslikely to be visible.

“Healing by secondary intention” as used herein includes a lessorganized wound healing process wherein healing occurs with lessalignment of normal anatomical structures and with an increaseddeposition of scar collagen. Morphologically, the scar is more likely tobe visible.

“Homograft” as used herein includes a graft taken from a different humanand applied as a temporary biological dressing to a recipient site on apatient. Most homografts are harvested as cadaver skin. A temporary“take” of a homograft can be partially achieved with immunosuppressionbut homografts are eventually replaced by autografts if the patientsurvives.

“Incise” as used herein includes the making of a surgical incisionwithout removal of tissue.

“Mesh Split Thickness Skin Graft” as used herein includes a splitthickness skin graft that is expanded in its surface area byrepetitiously incising the harvested skin graft with an instrumentcalled a “mesher”. A meshed split thickness skin graft has a higherpercentage of “take” than a sheet graft because it allows drainagethrough the graft and conforms better to the contour irregularities ofthe recipient site. However, it does result in an unsightly reticulatedappearance of the graft at the recipient site.

“PAD” as used herein includes a Pixel Array Dermatome, the class ofinstruments for fractional skin resection.

“PAD Kit” as used herein includes the disposable single use procedurekit comprising the perforated guide plate, scalpet stamper, the guideplate frame, the backed adherent membrane and the transection blade.

“Perforated Guide Plate” as used herein includes a perforated platecomprising the entire graft harvest area in which the holes of the guideplate are aligned with the scalpets of the handled stamper or theSlip-on PAD. The plate will also function as a guard to preventinadvertent laceration of the adjacent skin. The perforations of theGuide Plate can be different geometries such as, but not limited to,round, oval, square. rectangular, and/or triangular.

“Pixelated Full Thickness Skin Graft” as used herein includes a FullThickness Skin Graft that has been harvested with an instrument asdescribed herein without reduced visibly apparent scarring at the donorsite. The graft will also possess an enhanced appearance at therecipient site similar to a sheet FTSG but will conform better torecipient site and will have a higher percentage of ‘take’ due todrainage interstices between skin plugs. Another significant advantageof the pixelated FTSG in comparison to a sheet FTSG is the ability tograft larger surface areas that would otherwise require a STSG. Thisadvantage is due to the capability to harvest from multiple donor siteswith reduced visible scarring.

“Pixelated Graft Harvest” as used herein includes the skin graftharvesting from a donor site by an instrument as described in detailherein.

“Pixelated Spilt Thickness Skin Graft” as used herein includes a partialthickness skin graft that has been harvested with an SRG instrument. Theskin graft shares the advantages of a meshed skin graft withoutunsightly donor and recipient sites.

“Recipient Site” as used herein includes the skin defect site where askin graft is applied.

“Resect” as used herein includes excising.

“Scalpel” as used herein includes the single-edged knife that incisesskin and soft tissue.

“Scalpet” as used herein includes the term that describes the smallgeometrically-shaped (e.g., circle, ellipse, rectangle, square, etc.)scalpel that incises a plug of skin.

“Scalpet Array” as used herein includes the arrangement or array ofmultiple scalpets secured to a substrate (e.g., a base plate, stamper,handled stamper, tip, disposable tip, etc.).

“Scalpet Stamper” as used herein includes a handled scalpet arrayinstrument component of the PAD Kit that incises skin plugs through theperforated guide plate.

“Scar” as used herein includes the histological deposition ofdisorganized collagen following wounding, or the morphological deformitythat is visually apparent from the histological deposition ofdisorganized collagen following wounding.

“Sheet Full Thickness Skin Graft” as used herein includes reference toapplication of the FTSG at the recipient site as continuous sheet. Theappearance of an FTSG is superior to the appearance of a STSG and forthis reason it is primarily used for skin grafting in visually apparentareas such as the face.

“Sheet Split Thickness Skin Graft” as used herein includes a partialthickness skin graft that is a continuous sheet and is associated withthe typical donor site deformity.

“Skin Defect” as used herein includes the absence of the full thicknessof skin that may also include the subcutaneous fat layer and deeperstructures such as muscle. Skin defects can occur from a variety ofcauses i.e., burns, trauma, surgical excision of malignancies and thecorrection of congenital deformities.

“Skin Pixel” as used herein includes a piece of skin comprisingepidermis and a partial or full thickness of the dermis that is cut bythe scalpet; the skin pixel may include skin adnexa such as a hairfollicle with or without a cuff of subcutaneous fat; also includes SkinPlug.

“Skin Plug” as used herein includes a circular (or other geometricshaped) piece of skin comprising epidermis and a partial or fullthickness of the dermis that is incised by the scalpet, transected bythe transection blade and captured by the adherent-backed membrane.

“STSG” as used herein includes the Partial Thickness Skin Graft in whichthe epidermis and a portion of the dermis is harvested with the graft.

“Subcutaneous Fat Layer” as used herein includes the layer that isimmediately below the skin and is principally comprised of fat cellsreferred to as lipocytes. This layer functions as principle insulationlayer from the environment.

“Transection Blade” as used herein includes a horizontally-alignedsingle edged blade that can be either slotted to the frame of theperforated plate or attached to the outrigger arm of the drum dermatomeas described in detail herein. The transection blade transects the baseof the incised skin plugs.

“Wound Healing” as used herein includes the obligate biological processthat occurs from any type of wounding whether it be one or more ofthermal, kinetic and surgical.

“Xenograft” as used herein includes a graft taken from a differentspecies and applied as a temporary biological dressing to a recipientsite on a patient.

Multiple embodiments of pixel array medical systems, instruments ordevices, and methods for use are described in detail herein. Thesystems, instruments or devices, and methods described herein compriseminimally invasive surgical approaches for skin grafting and for skinresection that tightens lax skin without visible scarring via a deviceused in various surgical procedures such as plastic surgery procedures,and additionally for hair transplantation. In some embodiments, thedevice is a single use disposable instrument. The embodiments hereincircumvent surgically related scarring and the clinical variability ofelectromagnetic heating of the skin and perform small multiple pixilatedresections of skin as a minimally invasive alternative to large plasticsurgical resections of skin. The embodiments herein can also be employedin hair transplantation, and in areas of the body that may be off limitsto plastic surgery due to the visibility of the surgical scar. Inaddition, the approach can perform a skin grafting operation byharvesting the transected incisions of skin from a tissue site of adonor onto a skin defect site of a recipient with reduced scarring ofthe patient's donor site.

For many patients who have age related skin laxity (for non-limitingexamples, neck and face, arms, axillas, thighs, knees, buttocks,abdomen, bra line, ptosis of the breast, etc.), the minimally invasivepixel array medical devices and methods herein perform pixilatedtransection/resection of excess skin, replacing plastic surgery with itsincumbent scarring. Generally, the procedures described herein areperformed in an office setting under a local anesthetic with minimalperioperative discomfort, but are not so limited. In comparison to aprolonged healing phase from plastic surgery, only a short recoveryperiod is required, preferably applying a dressing and a support garmentworn over the treatment area for a pre-specified period of time (e.g., 5days, 7 days, etc.). There will be minimal or no pain associated withthe procedure.

The relatively small (e.g., in a range of approximately 0.5 mm to 4.0mm) skin defects generated by the instrumentation described herein areclosed with the application of an adherent Flexan® sheet. Functioning asa large butterfly bandage, the Flexan® sheet can be pulled in adirection (“vector”) that maximizes the aesthetic contouring of thetreatment area. A compressive elastic garment is applied over thedressing to further assist aesthetic contouring. After completion of theinitial healing phase, the multiplicity of small linear scars within thetreatment area will have reduced visibility in comparison to largerplastic surgical incisions on the same area. Additional skin tighteningis likely to occur over several months due to the delayed wound healingresponse. Other potential applications of the embodiments describedherein include hair transplantation as well as the treatment ofAlopecia, Snoring/Sleep apnea, Orthopedics/Physiatry, VaginalTightening, Female Urinary incontinence, and tightening ofgastrointestinal sphincters.

Significant burns are classified by the total body surface burned and bythe depth of thermal destruction, and the methods used to manage theseburns depend largely on the classification. First-degree andsecond-degree burns are usually managed in a non-surgical fashion withthe application of topical creams and burn dressings. Deeperthird-degree burns involve the full thickness thermal destruction of theskin, creating a full thickness skin defect. The surgical management ofthis serious injury usually involves the debridement of the burn escharand the application of split thickness grafts.

A full thickness skin defect, most frequently created from burning,trauma, or the resection of a skin malignancy, can be closed with eitherskin flap transfers or skin grafts using conventional commercialinstrumentation. Both surgical approaches require harvesting from adonor site. The use of a skin flap is further limited by the need of toinclude a pedicle blood supply and in most cases by the need to directlyclose the donor site.

The split thickness skin graft procedure, due to immunologicalconstraints, requires the harvesting of autologous skin grafts from thesame patient. Typically, the donor site on the burn patient is chosen ina non-burned area and a partial thickness sheet of skin is harvestedfrom that area. Incumbent upon this procedure is the creation of apartial thickness skin defect at the donor site. This donor site defectitself is similar to a deep second-degree burn. Healing byre-epithelialization of this site is often painful and may be prolongedfor several days. In addition, a visible donor site deformity istypically created that is permanently thinner and more de-pigmented thanthe surrounding skin. For patients who have burns over a significantsurface area, the extensive harvesting of skin grafts may also belimited by the availability of non-burned areas.

Both conventional surgical approaches to close skin defects (flaptransfer and skin grafting) are not only associated with significantscarring of the skin defect recipient site but also with the donor sitefrom which the graft is harvested. In contrast to the conventionalprocedures, embodiments described herein comprise Pixel Skin GraftingProcedures, also referred to as a pixel array procedures, that eliminatethis donor site deformity and provide a method to re-harvest skin graftsfrom any pre-existing donor site including either sheet or pixelateddonor sites. This ability to re-harvest skin grafts from pre-existingdonor sites will reduce the surface area requirement for donor site skinand provide additional skin grafting capability in severely burnedpatients who have limited surface area of unburned donor skin.

The Pixel Skin Grafting Procedure of an embodiment is used as a fullthickness skin graft. Many clinical applications such as facial skingrafting, hand surgery, and the repair of congenital deformities arebest performed with full thickness skin grafts. The texture,pigmentation and overall morphology of a full thickness skin graft moreclosely resembles the skin adjacent to a defect than a split thicknessskin graft. For this reason, full thickness skin grafting in visiblyapparent areas is superior in appearance than split thickness skingrafts. The main drawback to full thickness skin grafts underconventional procedures is the extensive linear scarring created fromthe surgical closure of the full thickness donor site defect; thisscarring limits the size and utility of full thickness skin grafting.

In comparison, the full thickness skin grafting of the Pixel SkinGrafting Procedure described herein is less limited by size and utilityas the linear donor site scar is eliminated. Thus, many skin defectsroutinely covered with split thickness skin grafts will instead betreated using pixelated full thickness skin grafts.

The Pixel Skin Grafting Procedure provides the capability to harvestsplit thickness and full thickness skin grafts with minimal visiblescarring of the donor site. During the procedure, a Pixel ArrayDermatome (PAD) device is used to harvest the skin graft from a chosendonor site. During the harvesting procedure, the pixilated skin graft isdeposited onto an adherent membrane. The adherent membrane of anembodiment includes a flexible, semi-porous, adherent membrane, but theembodiment is not so limited. The harvested skin graft/membranecomposite is then applied directly to the recipient skin defect site.The fractionally resected donor site is closed with the application ofan adherent Flexan® sheeting that functions for one week as a largebutterfly bandage. The relatively small (e.g., 1.5 mm) intradermalcircular skin defects are closed to promote a primary healing process inwhich the normal epidermal-dermal architecture is realigned in ananatomical fashion to minimize scarring. Also occurring approximatelyone week postoperatively, the adherent membrane is desquamated (shed)with the stratum corneum of the graft; the membrane can then be removedwithout disruption of the graft from the recipient bed. Thus, healing ofthe donor site occurs rapidly with minimal discomfort and scarring.

Because the skin graft at the recipient defect site using the Pixel SkinGrafting Procedure is pixelated it provides interstices for drainagebetween skin pixel components, which enhances the percentage of “takes,”compared to sheet skin grafts. During the first post-operative week(approximate), the skin graft will “take” at the recipient site by aprocess of neovascularization in which new vessels from the recipientbed of the skin defect grow into the new skin graft. The semi-porousmembrane will conduct the transudate (fluid) into the dressing.Furthermore, the flexible membrane is designed with an elastic recoilproperty that promotes apposition of component skin pixels within thegraft/membrane composite and promotes primary adjacent healing of theskin graft pixels, converting the pixilated appearance of the skin graftto a uniform sheet morphology. Additionally, the membrane aligns themicro-architectural component skin pixels, so epidermis aligns withepidermis and dermis aligns with dermis, promoting a primary healingprocess that reduces scarring. Moreover, pixelated skin grafts moreeasily conform to an irregular recipient site.

Embodiments described herein also include a Pixel Skin ResectionProcedure, also referred to herein as the Pixel Procedure. For manypatients who have age related skin laxity (neck and face, arms, axillas,thighs, knees, buttocks, abdomen, bra line, ptosis of the breast, etc.),fractional resection of excess skin could replace a significant segmentof plastic surgery with its incumbent scarring. Generally, the PixelProcedure will be performed in an office setting under a localanesthetic. The post procedure recovery period includes wearing of asupport garment over the treatment area for a pre-specified number(e.g., five, seven, etc.) of days (e.g., five days, seven days, etc.).Relatively little or no pain is anticipated to be associated with theprocedure. The small (e.g., 1.5 mm) circular skin defects will be closedwith the application of an adherent Flexan® sheet. Functioning as alarge butterfly bandage, the Flexan® sheet is pulled in a direction(“vector”) that maximizes the aesthetic contouring of the treatmentarea. A compressive elastic garment is then applied over the dressing tofurther assist aesthetic contouring. After completion of the initialhealing phase, the multiplicity of small linear scars within thetreatment area will not be visibly apparent. Furthermore, additionalskin tightening will subsequently occur over several months due to thedelayed wound healing response. Consequently, the Pixel Procedure is aminimally invasive alternative to the extensive scarring of PlasticSurgery.

The pixel array medical devices of an embodiment include a PAD Kit. FIG.1 shows the PAD Kit placed at a target site, under an embodiment. ThePAD Kit comprises a flat perforated guide plate (guide plate), a scalpetpunch or device that includes a scalpet array (FIGS. 1-3), a backedadhesive membrane or adherent substrate (FIG. 4), and a skin pixeltransection blade (FIG. 5), but is not so limited. The scalpet punch ofan embodiment is a handheld device but is not so limited. The guideplate is optional in an alternative embodiment, as described in detailherein.

FIG. 2 is a cross-section of a PAD Kit scalpet punch including a scalpetarray, under an embodiment. The scalpet array includes one or morescalpets. FIG. 3 is a partial cross-section of a PAD Kit scalpet punchincluding a scalpet array, under an embodiment. The partialcross-section shows the total length of the scalpets of the scalpetarray is determined by the thickness of the perforated guide plate andthe incisional depth into the skin, but the embodiment is not solimited.

FIG. 4 shows the adhesive membrane with backing (adherent substrate)included in a PAD Kit, under an embodiment. The undersurface of theadhesive membrane is applied to the incised skin at the target site.

FIG. 5 shows the adhesive membrane (adherent substrate) when used withthe PAD Kit frame and blade assembly, under an embodiment. The topsurface of the adhesive membrane is oriented with the adhesive side downinside the frame and then pressed over the perforated plate to capturethe extruded skin pixels, also referred to herein as plugs or skinplugs.

With reference to FIG. 1, the perforated guide plate is applied to theskin resection/donor site during a procedure using the PAD Kit. Thescalpet punch is applied through at least a set of perforations of theperforated guide plate to incise the skin pixels. The scalpet punch isapplied numerous times to a number of sets of perforations when thescalpet array of the punch includes fewer scalpets then the total numberof perforations of the guide plate. Following one or more serialapplications with the scalpet punch, the incised skin pixels or plugsare captured onto the adherent substrate. The adherent substrate is thenapplied in a manner so the adhesive captures the extruded skin pixels orplugs. As an example, the top surface of the adherent substrate of anembodiment is oriented with the adhesive side down inside the frame(when the frame is used) and then pressed over the perforated plate tocapture the extruded skin pixels or plugs. As the membrane is pulled up,the captured skin pixels are transected at their base by the transectionblade.

FIG. 6 shows the removal of skin pixels, under an embodiment. Theadherent substrate is pulled up and back (away) from the target site,and this act lifts or pulls the incised skin pixels or plugs. As theadherent substrate is being pulled up, the transection blade is used totransect the bases of the incised skin pixels. FIG. 7 is a side view ofblade transection and removal of incised skin pixels with the PAD Kit,under an embodiment. Pixel harvesting is completed with the transectionof the base of the skin pixels or plugs. FIG. 8 is an isometric view ofblade/pixel interaction during a procedure using the PAD Kit, under anembodiment. FIG. 9 is another view during a procedure using the PAD Kit(blade removed for clarity) showing both harvested skin pixels or plugstransected and captured and non-transected skin pixels or plugs prior totransection, under an embodiment. At the donor site, the pixelated skinresection sites are closed with the application of Flexan® sheeting.

The guide plate and scalpet device are also used to generate skindefects at the recipient site. The skin defects are configured toreceive the skin pixels harvested or captured at the donor site. Theguide plate used at the recipient site can be the same guide plate usedat the donor site, or can be different with a different pattern orconfiguration of perforations.

The skin pixels or plugs deposited onto the adherent substrate duringthe transection can next be transferred to the skin defect site(recipient site) where they are applied as a pixelated skin graft at arecipient skin defect site. The adherent substrate has an elastic recoilproperty that enables closer alignment of the skin pixels or plugswithin the skin graft. The incised skin pixels can be applied from theadherent substrate directly to the skin defects at the recipient site.Application of the incised skin pixels at the recipient site includesaligning the incised skin pixels with the skin defects, and insertingthe incised skin pixels into corresponding skin defects at the recipientsite.

The pixel array medical devices of an embodiment include a Pixel ArrayDermatome (PAD). The PAD comprises a flat array of relatively smallcircular scalpets that are secured onto a substrate (e.g., investingplate), and the scalpets in combination with the substrate are referredto herein as a scalpet array, pixel array, or scalpet plate. FIG. 10A isa side view of a portion of the pixel array showing scalpets securedonto an investing plate, under an embodiment. FIG. 10B is a side view ofa portion of the pixel array showing scalpets secured onto an investingplate, under an alternative embodiment. FIG. 10C is a top view of thescalpet plate, under an embodiment. FIG. 10D is a close view of aportion of the scalpet plate, under an embodiment. The scalpet plate isapplied directly to the skin surface. One or more scalpets of thescalpet array include one or more of a pointed surface, a needle, and aneedle including multiple points.

Embodiments of the pixel array medical devices and methods include useof a harvest pattern instead of the guide plate. The harvest patterncomprises indicators or markers on a skin surface on at least one of thedonor site and the recipient site, but is not so limited. The markersinclude any compound that may be applied directly to the skin to mark anarea of the skin. The harvest pattern is positioned at a donor site, andthe scalpet array of the device is aligned with or according to theharvest pattern at the donor site. The skin pixels are incised at thedonor site with the scalpet array as described herein. The recipientsite is prepared by positioning the harvest pattern at the recipientsite. The harvest pattern used at the recipient site can be the sameharvest pattern used at the donor site, or can be different with adifferent pattern or configuration of markers. The skin defects aregenerated, and the incised skin pixels are applied at the recipient siteas described herein. Alternatively, the guide plate of an embodiment isused in applying the harvest pattern, but the embodiment is not solimited.

To leverage established surgical instrumentation, the array of anembodiment is used in conjunction with or as a modification to a drumdermatome, for example a Padget dermatome or a Reese dermatome, but isnot so limited. The Padget drum dermatome referenced herein wasoriginally developed by Dr. Earl Padget in the 1930s, and continues tobe widely utilized for skin grafting by plastic surgeons throughout theworld. The Reese modification of the Padget dermatome was subsequentlydeveloped to better calibrate the thickness of the harvested skin graft.The drum dermatome of an embodiment is a single use (per procedure)disposable, but is not so limited.

Generally, FIG. 11A shows an example of a rolling pixel drum 100, underan embodiment. FIG. 11B shows an example of a rolling pixel drum 100assembled on a handle, under an embodiment. More specifically, FIG. 11Cdepicts a drum dermatome for use with the scalpet plate, under anembodiment.

Generally, as with all pixel devices described herein, the geometry ofthe pixel drum 100 can be a variety of shapes without limitation e.g.,circular, semicircular, elliptical, square, flat, or rectangular. Insome embodiments, the pixel drum 100 is supported by an axel/handleassembly 102 and rotated around a drum rotational component 104 poweredby, e.g., an electric motor. In some embodiments, the pixel drum 100 canbe placed on stand (not shown) when not in use, wherein the stand canalso function as a battery recharger for the powered rotationalcomponent of the drum or the powered component of the syringe plunger.In some embodiments, a vacuum (not shown) can be applied to the skinsurface of the pixel drum 100 and outriggers (not shown) can be deployedfor tracking and stability of the pixel drum 100.

In some embodiments, the pixel drum 100 incorporates an array ofscalpets 106 on the surface of the drum 100 to create small multiple(e.g., 0.5-1.5 mm) circular incisions referred to herein as skin plugs.In some embodiments, the border geometry of the scalpets can be designedto reduce pin cushioning (“trap door”) while creating the skin plugs.The perimeter of each skin plug can also be lengthened by the scalpetsto, for a non-limiting example, a, semicircular, elliptical, orsquare-shaped skin plug instead of a circular-shaped skin plug. In someembodiments, the length of the scalpets 106 may vary depending upon thethickness of the skin area selected by the surgeon for skin graftingpurposes, i.e., partial thickness or full thickness.

When the drum 100 is applied to a skin surface, a blade 108 placedinternal of the drum 100 transects the base of each skin plug created bythe array of scalpets, wherein the internal blade 108 is connected tothe central drum axel/handle assembly 102 and/or connected to outriggersattached to the central axel assembly 102. In some alternativeembodiments, the internal blade 108 is not connected to the drum axelassembly 102 where the base of the incisions of skin is transected. Insome embodiments, the internal blade 108 of the pixel drum 100 mayoscillate either manually or be powered by an electric motor. Dependingupon the density of the circular scalpets on the drum, a variablepercentage of skin (e.g., 20%, 30%, 40%, etc.) can be transected withinan area of excessive skin laxity.

In some embodiments, an added pixel drum harvester 112 is placed insidethe drum 100 to perform a skin grafting operation by harvesting andaligning the transected/pixilated skin incisions/plugs (pixel graft)from tissue of a pixel donor onto an adherent membrane 110 lined in theinterior of the pixel drum 100. A narrow space is created between thearray of scalpets 106 and the adherent membrane 110 for the internalblade 108.

In an embodiment, the blade 108 is placed external to the drum 100 andthe scalpet array 106 where the base of the incised circular skin plugsis transected. In another embodiment, the external blade 108 isconnected to the drum axel assembly 102 when the base of the incisionsof skin is transected. In an alternative embodiment, the external blade108 is not connected to the drum axel assembly 102 when the base of theincisions of skin is transected. The adherent membrane 110 that extractsand aligns the transected skin segments is subsequently placed over askin defect site of a patient. The blade 108 (either internal orexternal) can be a fenestrated layer of blade aligned to the scalpetarray 106, but is not so limited.

The conformable adherent membrane 110 of an embodiment can besemi-porous to allow for drainage at a recipient skin defect when themembrane with the aligned transected skin segments is extracted from thedrum and applied as a skin graft. The adherent semi-porous drum membrane110 can also have an elastic recoil property to bring thetransected/pixilated skin plugs together for grafting onto the skindefect site of the recipient, i.e., the margins of each skin plug can bebrought closer together as a more uniform sheet after the adherentmembrane with pixilated grafts extracted from the drum 100.Alternatively, the adherent semi-porous drum membrane 110 can beexpandable to cover a large surface area of the skin defect site of therecipient. In some embodiments, a sheet of adhesive backer 111 can beapplied between the adherent membrane 110 and the drum harvester 112.The drum array of scalpets 106, blade 108, and adherent membrane 110 canbe assembled together as a sleeve onto a preexisting drum 100, asdescribed in detail herein.

The internal drum harvester 112 of the pixel drum 110 of an embodimentis disposable and replaceable. Limit and/or control the use of thedisposable components can be accomplished by means that includes but isnot limited to electronic, EPROM, mechanical, durability. The electronicand/or mechanical records and/or limits of number of drum rotations forthe disposable drum as well as the time of use for the disposable drumcan be recorded, controlled and/or limited either electronically ormechanically.

During the harvesting portion of the procedure with a drum dermatome,the PAD scalpet array is applied directly to the skin surface. Tocircumferentially incise the skin pixels, the drum dermatome ispositioned over the scalpet array to apply a load onto the subjacentskin surface. With a continuing load, the incised skin pixels areextruded through the holes of the scalpet array and captured onto anadherent membrane on the drum dermatome. The cutting outrigger blade ofthe dermatome (positioned over the scalpet array) transects the base ofextruded skin pixels. The membrane and the pixelated skin composite arethen removed from the dermatome drum, to be directly applied to therecipient skin defect as a skin graft.

With reference to FIG. 11C, an embodiment includes a drum dermatome foruse with the scalpet plate, as described herein. More particularly, FIG.12A shows the drum dermatome positioned over the scalpet plate, under anembodiment. FIG. 12B is an alternative view of the drum dermatomepositioned over the scalpet plate, under an embodiment. The cuttingoutrigger blade of the drum dermatome is positioned on top of thescalpet array where the extruded skin plugs will be transected at theirbase.

FIG. 13A is an isometric view of application of the drum dermatome(e.g., Padgett dermatome) over the scalpet plate, where the adhesivemembrane is applied to the drum of the dermatome before rolling it overthe investing plate, under an embodiment. FIG. 13B is a side view of aportion of the drum dermatome showing a blade position relative to thescalpet plate, under an embodiment. FIG. 13C is a side view of theportion of the drum dermatome showing a different blade positionrelative to the scalpet plate, under an embodiment. FIG. 13D is a sideview of the drum dermatome with another blade position relative to thescalpet plate, under an embodiment. FIG. 13E is a side view of the drumdermatome with the transection blade clip showing transection of skinpixels by the blade clip, under an embodiment. FIG. 13F is a bottom viewof the drum dermatome along with the scalpet plate, under an embodiment.FIG. 13G is a front view of the drum dermatome along with the scalpetplate, under an embodiment. FIG. 13H is a back view of the drumdermatome along with the scalpet plate, under an embodiment.

Depending upon the clinical application, the disposable adherentmembrane of the drum dermatome can be used to deposit/dispose ofresected lax skin or harvest/align a pixilated skin graft.

Embodiments described herein also include a Pixel Onlay Sleeve (POS) foruse with the dermatomes, for example the Padget dermatomes and Reesedermatomes. FIG. 14A shows an assembled view of the dermatome with thePixel Onlay Sleeve (POS), under an embodiment. The POS comprises thedermatome and blade incorporated with an adhesive backer, adhesive, anda scalpet array. The adhesive backer, adhesive, and scalpet array areintegral to the device, but are not so limited. FIG. 14B is an explodedview of the dermatome with the Pixel Onlay Sleeve (POS), under anembodiment. FIG. 14C shows a portion of the dermatome with the PixelOnlay Sleeve (POS), under an embodiment.

The POS, also referred to herein as the “sleeve,” provides a disposabledrum dermatome onlay for the fractional resection of redundant lax skinand the fractional skin grafting of skin defects. The onlay sleeve isused in conjunction with either the Padget and Reese dermatomes as asingle use disposable component. The POS of an embodiment is athree-sided slip-on disposable sleeve that slips onto a drum dermatome.The device comprises an adherent membrane and a scalpet drum array withan internal transection blade. The transection blade of an embodimentincludes a single-sided cutting surface that sweeps across the internalsurface of the scalpet drum array.

In an alternative blade embodiment, a fenestrated cutting layer coversthe internal surface of the scalpet array. Each fenestration with itscutting surface is aligned with each individual scalpet. Instead ofsweeping motion to transect the base of the skin plugs, the fenestratedcutting layer oscillates over the scalpet drum array. A narrow spacebetween the adherent membrane and the scalpet array is created forexcursion of the blade. For multiple harvesting during a skin graftingprocedure, an insertion slot for additional adherent membranes isprovided. The protective layer over the adherent membrane is pealed awayinsitu with an elongated extraction tab that is pulled from anextraction slot on the opposite side of the sleeve assembly. As withother pixel device embodiments, the adherent membrane is semi-porous fordrainage at the recipient skin defect site. To morph the pixilated skingraft into a more continuous sheet, the membrane may also have anelastic recoil property to provide closer alignment of the skin plugswithin the skin graft.

Embodiments described herein include a Slip-On PAD that is configured asa single-use disposable device with either the Padgett or Reesedermatomes. FIG. 15A shows the Slip-On PAD being slid onto a PadgettDrum Dermatome, under an embodiment. FIG. 15B shows an assembled view ofthe Slip-On PAD installed over the Padgett Drum Dermatome, under anembodiment.

The Slip-on PAD of an embodiment is used (optionally) in combinationwith a perforated guide plate. FIG. 16A shows the Slip-On PAD installedover a Padgett Drum Dermatome and used with a perforated template orguide plate, under an embodiment. The perforated guide plate is placedover the target skin site and held in place with adhesive on the bottomsurface of the apron to maintain orientation. The Padgett Dermatome withSlip-On PAD is rolled over the perforated guide plate on the skin.

FIG. 16B shows skin pixel harvesting with a Padgett Drum Dermatome andinstalled Slip-On PAD, under an embodiment. For skin pixel harvesting,the Slip-On PAD is removed, adhesive tape is applied over the drum ofthe Padgett dermatome, and the clip-on blade is installed on theoutrigger arm of the dermatome, which then is used to transect the baseof the skin pixels. The Slip-on PAD of an embodiment is also used(optionally) with standard surgical instrumentation such as a ribbonretractor to protect the adjacent skin of the donor site.

Embodiments of the pixel instruments described herein include a PixelDrum Dermatome (PD2) that is a single use disposable instrument ordevice. The PD2 comprises a cylinder or rolling/rotating drum coupled toa handle, and the cylinder includes a Scalpet Drum Array. An internalblade is interlocked to the drum axle/handle assembly and/or interlockedto outriggers attached to the central axle. As with the PAD and the POSdescribed herein, small multiple pixilated resections of skin areperformed directly in the region of skin laxity, thereby enhancing skintightening with minimal visible scarring.

FIG. 17A shows an example of a Pixel Drum Dermatome being applied to atarget site of the skin surface, under an embodiment. FIG. 17B shows analternative view of a portion of the Pixel Drum Dermatome being appliedto a target site of the skin surface, under an embodiment.

The PD2 device applies a full rolling/rotating drum to the skin surfacewhere multiple small (e.g., 1.5 mm) circular incisions are created atthe target site with a “Scalpet Drum Array”. The base of each skin plugis then transected with an internal blade that is interlocked to thecentral drum axel/handle assembly and/or interlocked to outriggersattached to the central axel. Depending upon the density of the circularscalpets on the drum, a variable percentage of skin can be resected. ThePD2 enables portions (e.g., 20%, 30%, 40%, etc.) of the skin's surfacearea to be resected without visible scarring in an area of excessiveskin laxity, but the embodiment is not so limited.

Another alternative embodiment of the pixel instruments presented hereinis the Pixel Drum Harvester (PDH). Similar to the Pixel Drum Dermatome,an added internal drum harvests and aligns the pixilated resections ofskin onto an adherent membrane that is then placed over a recipient skindefect site of the patient. The conformable adherent membrane issemi-porous to allow for drainage at a recipient skin defect when themembrane with the aligned resected skin segments is extracted from thedrum and applied as a skin graft. An elastic recoil property of themembrane allows closer approximation of the pixilated skin segments,partially converting the pixilated skin graft to a sheet graft at therecipient site.

The pixel array medical systems, instruments or devices, and methodsdescribed herein evoke or enable cellular and/or extracellular responsesthat are obligatory to the clinical outcomes achieved. For the pixeldermatomes, a physical reduction of the skin surface area occurs due tothe pixilated resection of skin, i.e., creation of the skin plugs. Inaddition, a subsequent tightening of the skin results due to the delayedwound healing response. Each pixilated resection initiates an obligatewound healing sequence in multiple phases as described in detail herein.

The first phase of this sequence is the inflammatory phase in whichdegranulation of mast cells release histamine into the “wound”.Histamine release may evoke dilatation of the capillary bed and increasevessel permeability into the extracellular space. This initial woundhealing response occurs within the first day and will be evident aserythema on the skin's surface.

The second phase (of Fibroplasia) commences within three to four days of“wounding”. During this phase, there is migration and mitoticmultiplication of fibroblasts. Fibroplasia of the wound includes thedeposition of neocollagen and the myofibroblastic contraction of thewound.

Histologically, the deposition of neocollagen can be identifiedmicroscopically as compaction and thickening of the dermis. Althoughthis is a static process, the tensile strength of the woundsignificantly increases. The other feature of Fibroplasia is a dynamicphysical process that results in a multi-dimensional contraction of thewound. This component feature of Fibroplasia is due to the activecellular contraction of myofibroblasts. Morphologically, myoblasticcontraction of the wound will be visualized as a two dimensionaltightening of the skin surface. Overall, the effect of Fibroplasia isdermal contraction along with the deposition of a static supportingscaffolding of neocollagen with a tightened framework. The clinicaleffect is seen as a delayed tightening of skin with smoothing of skintexture over several months. The clinical endpoint is generally a moreyouthful appearing skin envelope of the treatment area.

A third and final phase of the delayed wound healing response ismaturation. During this phase there is a strengthening and remodeling ofthe treatment area due to an increased cross-linkage of the collagenfibril matrix (of the dermis). This final stage commences within six totwelve months after “wounding” and may extend for at least one to twoyears. Small pixilated resections of skin should preserve the normaldermal architecture during this delayed wound healing process withoutthe creation of an evident scar that typically occurs with a largersurgical resection of skin. Lastly, there is a related stimulation andrejuvenation of the epidermis from the release of epidermal growthhormone. The delayed wound healing response can be evoked, with scarcollagen deposition, within tissues (such as muscle or fat) with minimalpre-existing collagen matrix.

Other than tightening skin for aesthetic purposes, the pixel arraymedical systems, instruments or devices, and methods described hereinmay have additional medically related applications. In some embodiments,the pixel array devices can transect a variable portion of any softtissue structure without resorting to a standard surgical resection.More specifically, the reduction of an actinic damaged area of skin viathe pixel array devices should reduce the incidence of skin cancer. Forthe treatment of sleep apnea and snoring, a pixilated mucosal reduction(soft palate, base of the tongue and lateral pharyngeal walls) via thepixel array devices would reduce the significant morbidity associatedwith more standard surgical procedures. For birth injuries of thevaginal vault, pixilated skin and vaginal mucosal resection via thepixel array devices would reestablish normal pre-partum geometry andfunction without resorting to an A&P resection. Related female stressincontinence could also be corrected in a similar fashion.

The pixel array dermatome (PAD) of an embodiment, also referred toherein as a scalpet device assembly, includes a system or kit comprisinga control device, also referred to as a punch impact hand-piece, and ascalpet device, also referred to as a tip device. The scalpet device,which is removeably coupled to the control device, includes an array ofscalpets positioned within the scalpet device. The removeable scalpetdevice of an embodiment is disposable and consequently configured foruse during a single procedure, but the embodiment is not so limited.

The PAD includes an apparatus comprising a housing configured to includea scalpet device. The scalpet device includes a substrate and a scalpetarray, and the scalpet array includes a plurality of scalpets arrangedin a configuration on the substrate. The substrate and the plurality ofscalpets are configured to be deployed from the housing and retractedinto the housing, and the plurality of scalpets is configured togenerate a plurality of incised skin pixels at a target site whendeployed. The proximal end of the control device is configured to behand-held. The housing is configured to be removeably coupled to areceiver that is a component of a control device. The control deviceincludes a proximal end that includes an actuator mechanism, and adistal end that includes the receiver. The control device is configuredto be disposable, but alternatively the control device is configured tobe at least one of cleaned, disinfected, and sterilized.

The scalpet array is configured to be deployed in response to activationof the actuator mechanism. The scalpet device of an embodiment isconfigured so the scalpet array is deployed from the scalpet device andretracted back into the scalpet device in response to activation of theactuator mechanism. The scalpet device of an alternative embodiment isconfigured so the scalpet array is deployed from the scalpet device inresponse to activation of the actuator mechanism, and retracted backinto the scalpet device in response to release of the actuatormechanism.

FIG. 18 shows a side perspective view of the PAD assembly, under anembodiment. The PAD assembly of this embodiment includes a controldevice configured to be hand-held, with an actuator or trigger and thescalpet device comprising the scalpet array. The control device isreusable, but alternative embodiments include a disposable controldevice. The scalpet array of an embodiment is configured to create orgenerate an array of incisions (e.g., 1.5 mm, 2 mm, 3 mm, etc.) asdescribed in detail herein. The scalpet device of an embodiment includesa spring-loaded array of scalpets configured to incise the skin asdescribed in detail herein, but the embodiments are not so limited.

FIG. 19A shows a top perspective view of the scalpet device for use withthe PAD assembly, under an embodiment. FIG. 19B shows a bottomperspective view of the scalpet device for use with the PAD assembly,under an embodiment. The scalpet device comprises a housing configuredto house a substrate that is coupled to or includes a plunger. Thehousing is configured so that a proximal end of the plunger protrudesthrough a top surface of the housing. The housing is configured to beremoveably coupled to the control device, and a length of the plunger isconfigured to protrude a distance through the top surface to contact thecontrol device and actuator when the scalpet device is coupled to thecontrol device.

The substrate of the scalpet device is configured to retain numerousscalpets that form the scalpet array. The scalpet array comprises apre-specified number of scalpets as appropriate to the procedure inwhich the scalpet device assembly is used. The scalpet device includesat least one spring mechanism configured to provide a downward, orimpact or punching, force in response to activation of the scalpet arraydevice, and this force assists generation of incisions (pixelated skinresection sites) by the scalpet array. Alternatively, the springmechanism can be configured to provide an upward, or retracting, forceto assist in retraction of the scalpet array.

One or more of the scalpet device and the control device of anembodiment includes an encryption system (e.g., EPROM, etc.). Theencryption system is configured to prevent illicit use and pirating ofthe scalpet devices and/or control devices, but is not so limited.

During a procedure, the scalpet device assembly is applied one time to atarget area or, alternative, applied serially within a designated targettreatment area of skin laxity. The pixelated skin resection sites withinthe treatment area are then closed with the application of Flexansheeting, as described in detail herein, and directed closure of thesepixelated resections is performed in a direction that provides thegreatest aesthetic correction of the treatment site.

The PAD device of an alternative embodiment includes a vacuum componentor system for removing incised skin pixels. FIG. 20 shows a side view ofthe punch impact device including a vacuum component, under anembodiment. The PAD of this example includes a vacuum system orcomponent within the control device to suction evacuate the incised skinpixels, but is not so limited. The vacuum component is removeablycoupled to the PAD device, and its use is optional. The vacuum componentis coupled to and configured to generate a low-pressure zone within oradjacent to one or more of the housing, the scalpet device, the scalpetarray, and the control device. The low-pressure zone is configured toevacuate the incised skin pixels.

The PAD device of another alternative embodiment includes a radiofrequency (RF) component or system for generating skin pixels. The RFcomponent is coupled to and configured to provide or couple energywithin or adjacent to one or more of the housing, the scalpet device,the scalpet array, and the control device. The RF component isremoveably coupled to the PAD device, and its use is optional. Theenergy provided by the RF component includes one or more of thermalenergy, vibrational energy, rotational energy, and acoustic energy, toname a few.

The PAD device of yet another alternative embodiment includes a vacuumcomponent or system and an RF component or system. The PAD of thisembodiment includes a vacuum system or component within the handpiece tosuction evacuate the incised skin pixels. The vacuum component isremoveably coupled to the PAD device, and its use is optional. Thevacuum component is coupled to and configured to generate a low-pressurezone within or adjacent to one or more of the housing, the scalpetdevice, the scalpet array, and the control device. The low-pressure zoneis configured to evacuate the incised skin pixels. Additionally, the PADdevice includes an RF component coupled to and configured to provide orcouple energy within or adjacent to one or more of the housing, thescalpet device, the scalpet array, and the control device. The RFcomponent is removeably coupled to the PAD device, and its use isoptional. The energy provided by the RF component includes one or moreof thermal energy, vibrational energy, rotational energy, and acousticenergy, to name a few.

As one particular example, the PAD of an embodiment includes anelectrosurgical generator configured to more effectively incise donorskin or skin plugs with minimal thermo-conductive damage to the adjacentskin. For this reason, the RF generator operates using relatively highpower levels with relatively short duty cycles, for example. The RFgenerator is configured to supply one or more of a powered impactorcomponent configured to provide additional compressive force forcutting, cycling impactors, vibratory impactors, and an ultrasonictransducer.

The PAD with RF of this example also includes a vacuum component, asdescribed herein. The vacuum component of this embodiment is configuredto apply a vacuum that pulls the skin up towards the scalpets (e.g.,into the lumen of the scalpets, etc.) to stabilize and promote the RFmediated incision of the skin within the fractional resection field, butis not so limited. One or more of the RF generator and the vacuumappliance is coupled to be under the control of a processor running asoftware application. Additionally, the PAD of this embodiment can beused with the guide plate as described in detail herein, but is not solimited.

In addition to fractional incision at a donor site, fractional skingrafting includes the harvesting and deposition of skin plugs (e.g.,onto an adherent membrane, etc.) for transfer to a recipient site. Aswith fractional skin resection, the use of a duty-driven RF cutting edgeon an array of scalpets facilitates incising donor skin plugs. The baseof the incised scalpets is then transected and harvested as described indetail herein.

The timing of the vacuum assisted component is processor controlled toprovide a prescribed sequence with the RF duty cycle. With softwarecontrol, different variations are possible to provide the optimalsequence of combined RF cutting with vacuum assistance. Withoutlimitation, these include an initial period of vacuum prior to the RFduty cycle. Subsequent to the RF duty cycle, a period during thesequence of an embodiment includes suction evacuation of the incisedskin plugs.

Other potential control sequences of the PAD include without limitationsimultaneous duty cycles of RF and vacuum assistance. Alternatively, acontrol sequence of an embodiment includes pulsing or cycling of the RFduty cycle within the sequence and/or with variations of RF power or theuse of generators at different RF frequencies.

Another alternative control sequence includes a designated RF cycleoccurring at the depth of the fractional incision. A lower power longerduration RF duty cycle with insulated shaft with an insulated shaft anactive cutting tip could generate a thermal-conductive lesion in thedeep dermal/subcutaneous tissue interface. The deep thermal lesion wouldevoke a delayed wound healing sequence that would secondarily tightenthe skin without burning of the skin surface.

With software control, different variations are possible to provide theoptimal sequence of combined RF cutting and powered mechanical cuttingwith vacuum assistance. Examples include but are not limited tocombinations of powered mechanical cutting with vacuum assistance, RFcutting with powered mechanical cutting and vacuum assistance, RFcutting with vacuum assistance, and RF cutting with vacuum assistance.Examples of combined software controlled duty cycles include but are notlimited to precutting vacuum skin stabilization period, RF cutting dutycycle with vacuum skin stabilization period, RF cutting duty cycle withvacuum skin stabilization and powered mechanical cutting period, poweredmechanical cutting with vacuum skin stabilization period, post cuttingRF duty cycle for thermal conductive heating of the deeper dermal and/orsubdermal tissue layer to evoke a wound healing response for skintightening, and a post cutting vacuum evacuation period for skintightening.

Another embodiment of pixel array medical devices described hereinincludes a device comprising an oscillating flat array of scalpets andblade either powered electrically or deployed manually (unpowered) andused for skin tightening as an alternative to the drum/cylinderdescribed herein. FIG. 21A shows a top view of an oscillating flatscalpet array and blade device, under an embodiment. FIG. 21B shows abottom view of an oscillating flat scalpet array and blade device, underan embodiment. Blade 108 can be a fenestrated layer of blade aligned tothe scalpet array 106. The instrument handle 102 is separated from theblade handle 103 and the adherent membrane 110 can be peeled away fromthe adhesive backer 111. FIG. 21C is a close-up view of the flat arraywhen the array of scalpets 106, blades 108, adherent membrane 110 andthe adhesive backer 111 are assembled together, under an embodiment. Asassembled, the flat array of scalpets can be metered to provide auniform harvest or a uniform resection. In some embodiments, the flatarray of scalpets may further include a feeder component 115 for theadherent harvesting membrane 110 and adhesive backer 111. FIG. 21D is aclose-up view of the flat array of scalpets with a feeder component 115,under an embodiment.

In another skin grafting embodiment, the pixel graft is placed onto anirradiated cadaver dermal matrix (not shown). When cultured onto thedermal matrix, a graft of full thickness skin is created for the patientthat is immunologically identical to the pixel donor. In embodiments,the cadaver dermal matrix can also be cylindrical transected similar insize to the harvested skin pixel grafts to provide histologicalalignment of the pixilated graft into the cadaver dermal framework. FIG.22 shows a cadaver dermal matrix cylindrically transected similar insize to the harvested skin pixel grafts, under an embodiment. In someembodiments, the percentage of harvest of the donor site can bedetermined in part by the induction of a normal dermal histology at theskin defect site of the recipient, i.e., a normal (smoother) surfacetopology of the skin graft is facilitated. With either the adherentmembrane or the dermal matrix embodiment, the pixel drum harvesterincludes the ability to harvest a large surface area for grafting withvisible scarring of the patient's donor site significantly reduced oreliminated.

In addition to the pixel array medical devices described herein,embodiments include drug delivery devices. For the most part, theparenteral delivery of drugs is still accomplished from an injectionwith a syringe and needle. To circumvent the negative features of theneedle and syringe system, the topical absorption of medicationtranscutaneously through an occlusive patch was developed. However, bothof these drug delivery systems have significant drawbacks. The humanaversion to a needle injection has not abated during the nearly twocenturies of its use. The variable systemic absorption of either asubcutaneous or intramuscular drug injection reduces drug efficacy andmay increase the incidence of adverse patient responses. Depending uponthe lipid or aqueous carrier fluid of the drug, the topically appliedocclusive patch is plagued with variable absorption across an epidermalbarrier. For patients who require local anesthesia over a large surfacearea of skin, neither the syringe/needle injections nor topicalanesthetics are ideal. The syringe/needle “field” injections are oftenpainful and may instill excessive amounts of the local anesthetic thatmay cause systemic toxicity. Topical anesthetics rarely provide thelevel of anesthesia required for skin related procedures.

FIG. 23 is a drum array drug delivery device 200, under an embodiment.The drug delivery device 200 successfully addresses the limitations anddrawbacks of other drug delivery systems. The device comprises adrum/cylinder 202 supported by an axel/handle assembly 204 and rotatedaround a drum rotation component 206. The handle assembly 204 of anembodiment further includes a reservoir 208 of drugs to be delivered anda syringe plunger 210. The surface of the drum 202 is covered by anarray of needles 212 of uniform length, which provide a uniformintradermal (or subdermal) injection depth with a more controlled volumeof the drug injected into the skin of the patient. During operation, thesyringe plunger 210 pushes the drug out of the reservoir 208 to beinjected into a sealed injection chamber 214 inside the drum 202 viaconnecting tube 216. The drug is eventually delivered into the patient'sskin at a uniform depth when the array of needles 212 is pushed into apatient's skin until the surface of the drum 202 hits the skin.Non-anesthetized skip area is avoided and a more uniform pattern ofcutaneous anesthesia is created. The rolling drum application of thedrug delivery device 200 also instills the local anesthetic faster withless discomfort to the patient.

FIG. 24A is a side view of a needle array drug delivery device 300,under an embodiment. FIG. 24B is an upper isometric view of a needlearray drug delivery device 300, under an embodiment. FIG. 24C is a lowerisometric view of a needle array drug delivery device 300, under anembodiment. The drug delivery device 300 comprises a flat array of fineneedles 312 of uniform length positioned on manifold 310 can be utilizedfor drug delivery. In this example embodiment, syringe 302 in which drugfor injection is contained can be plugged into a disposable adaptor 306with handles, and a seal 308 can be utilized to ensure that the syringe302 and the disposable adaptor 306 are securely coupled to each other.When the syringe plunger 304 is pushed, drug contained in syringe 302 isdelivered from syringe 302 into the disposable adaptor 306. The drug isfurther delivered into the patient's skin through the flat array of fineneedles 312 at a uniform depth when the array of needles 312 is pushedinto a patient's skin until manifold 310 hits the skin.

The use of the drug delivery device 200 may have as many clinicalapplications as the number of pharmacological agents that requiretranscutaneous injection or absorption. For non-limiting examples, a fewof the potential applications are the injection of local anesthetics,the injection of neuromodulators such as Botulinum toxin (Botox), theinjection of insulin and the injection of replacement estrogens andcorticosteroids.

In some embodiments, the syringe plunger 210 of the drug delivery device200 can be powered by, for a non-limiting example, an electric motor. Insome embodiments, a fluid pump (not shown) attached to an IV bag andtubing can be connected to the injection chamber 214 and/or thereservoir 208 for continuous injection. In some embodiments, the volumeof the syringe plunger 210 in the drug delivery device 200 is calibratedand programmable.

Another application of pixel skin graft harvesting with the PAD (PixelArray Dermatome) device as described in detail herein is Alopecia.Alopecia is a common aesthetic malady, and it occurs most frequently inthe middle-aged male population, but is also observed in the aging babyboomer female population. The most common form of alopecia is MalePattern Baldness (MPB) that occurs in the frontal-parietal region of thescalp. Male pattern baldness is a sex-linked trait that is transferredby the X chromosome from the mother to male offspring. For men, only onegene is needed to express this phenotype. As the gene is recessive,female pattern baldness requires the transfer of both X linked genesfrom both mother and father. Phenotypic penetrance can vary from patientto patient and is most frequently expressed in the age of onset and theamount of frontal/partial/occipital alopecia. The patient variability inthe phenotypic expression of MPB is due to the variable genotypictranslation of this sex-linked trait. Based upon the genotypicoccurrence of MPB, the need for hair transplantation is vast. Othernon-genetic related etiologies are seen in a more limited segment of thepopulation. These non-genetic etiologies include trauma, fungalinfections, lupus erythematosus, radiation and chemotherapy.

A large variety of treatment options have been proposed to the public.These include FDA approved topical medications such as Minoxidil andFinasteride which have had limited success as these agents require theconversion of dormant hair follicles into an anagen growth phase. Otherremedies include hairpieces and hair weaving. The standard of practiceremains surgical hair transplantation, which involves the transfer ofhair plugs, strips and flaps from the hair-bearing scalp into the nonhair-bearing scalp. For the most part, conventional hair transplantationinvolves the transfer of multiple single hair micrographs from thehair-bearing scalp to the non hair-bearing scalp of the same patient.Alternately, the donor plugs are initially harvested as hair strips andthen secondarily sectioned into micrographs for transfer to therecipient scalp. Regardless, this multi-staged procedure is both tediousand expensive, involving several hours of surgery for the averagepatient.

The conventional hair transplantation market has been encumbered bylengthy hair grafting procedures that are performed in several stages. Atypical hair grafting procedure involves the transfer of hair plugs froma donor site in the occipital scalp to a recipient site in the baldingfrontal-parietal scalp. For most procedures, each hair plug istransferred individually to the recipient scalp. Several hundred plugsmay be transplanted during a procedure that may require several hours toperform. Post procedure “take” or viability of the transplanted hairplugs is variable due to factors that limit neovascularization at therecipient site. Bleeding and mechanical disruption due to motion are keyfactors that reduce neovascularization and “take” of hair grafts.Embodiments described herein include surgical instrumentation configuredto transfer several hair grafts at once that are secured and aligned enmasse at a recipient site on the scalp. The procedures described hereinusing the PAD of an embodiment reduce the tedium and time required withconventional instrumentation.

FIG. 25 shows the composition of human skin. Skin comprises twohorizontally stratified layers, referred to as the epidermis and thedermis, acting as a biological barrier to the external environment. Theepidermis is the enveloping layer and comprises a viable layer ofepidermal cells that migrate upward and “mature” into a non-viable layercalled the stratum corneum. The stratum corneum is a lipid-keratincomposite that serves as a primary biological barrier, and this layer iscontinually shed and reconstituted in a process called desquamation. Thedermis is the subjacent layer that is the main structural support of theskin, and is predominately extracellular and is comprised of collagenfibers.

In addition to the horizontally stratified epidermis and dermis, theskin includes vertically-aligned elements or cellular appendagesincluding the pilosebaceous units, comprising the hair folical andsebacious gland. Pilosebaceous units each include a sebaceous oil glandand a hair follicle. The sebaceous gland is the most superficial anddischarges sebum (oil) into the shaft of the hair follicle. The base ofthe hair follicle is called the bulb and the base of the bulb has a deepgenerative component called the dermal papilla. The hair follicles aretypically aligned at an oblique angle to the skin surface. Hairfollicles in a given region of the scalp are aligned parallel to eachother. Although pilosebaceous units are common throughout the entireintegument, the density and activity of these units within a region ofthe scalp is a key determinate as to the overall appearance of hair.

In additional to pilosebaceous units, sweat glands also coursevertically through the skin. They provide a water-based transudate thatassists in thermoregulation. Apocrine sweat glands in the axilla andgroin express a more pungent sweat that is responsible for body odor.For the rest of the body, eccrine sweat glands excrete a less pungentsweat for thermoregulation.

Hair follicles proceed through different physiological cycles of hairgrowth. FIG. 26 shows the physiological cycles of hair growth. Thepresence of testosterone in a genetically-prone man will producealopecia to a variable degree in the frontal-parietal scalp.Essentially, the follicle becomes dormant by entering the telogen phasewithout return to the anagen phase. Male Pattern Baldness occurs whenthe hair fails to return from the telogen phase to the anagen phase.

The PAD of an embodiment is configured for en-masse harvesting ofhair-bearing plugs with en-masse transplantation of hair bearing plugsinto non hair-bearing scalp, which truncates conventional surgicalprocedures of hair transplantation. Generally, the devices, systemsand/or methods of an embodiment are used to harvest and align a largemultiplicity of small hair bearing plugs in a single surgical step orprocess, and the same instrumentation is used to prepare the recipientsite by performing a multiple pixelated resection of non hair-bearingscalp. The multiple hair-plug graft is transferred and transplanteden-masse to the prepared recipient site. Consequently, through use of anabbreviated procedure, hundreds of hair bearing plugs can be transferredfrom a donor site to a recipient site. Hair transplantation using theembodiments described herein therefore provides a solution that is asingle surgical procedure having ease, simplicity and significant timereduction over the tedious and multiple staged conventional process.

Hair transplantation using the pixel dermatome of an embodimentfacilitates improvements in the conventional standard follicular unitextraction (FUT) hair transplant approach. Generally, under theprocedure of an embodiment hair follicles to be harvested are taken fromthe Occipital scalp of the donor. In so doing, the donor site hair ispartially shaved, and the perforated plate of an embodiment is locatedon the scalp and oriented to provide a maximum harvest. FIG. 27 showsharvesting of donor follicles, under an embodiment. The scalpets in thescalpet array are configured to penetrate down to the subcutaneous fatlater to capture the hair follicle. Once the hair plugs are incised,they are harvested onto an adhesive membrane by transecting the base ofthe hair plug with the transection blade, as described in detail herein.Original alignment of the hair plugs with respect to each other at thedonor site is maintained by applying the adherent membrane beforetransecting the base. The aligned matrix of hair plugs on the adherentmembrane will then be grafted en masse to a recipient site on thefrontal-parietal scalp of the recipient.

FIG. 28 shows preparation of the recipient site, under an embodiment.The recipient site is prepared by resection of non-hair bearing skinplugs in a topographically identical pattern as the harvested occipitalscalp donor site. The recipient site is prepared for the mass transplantof the hair plugs using the same instrumentation that was used at thedonor site under an embodiment and, in so doing, scalp defects arecreated at the recipient site. The scalp defects created at therecipient site have the same geometry as the harvested plugs on theadherent membrane.

The adherent membrane laden with the harvested hair plugs is appliedover the same pattern of scalp defects at the recipient site.Row-by-row, each hair-bearing plug is inserted into its mirror imagerecipient defect. FIG. 29 shows placement of the harvested hair plugs atthe recipient site, under an embodiment. Plug-to-plug alignment ismaintained, so the hair that grows from the transplanted hair plugs laysas naturally as it did at the donor site. More uniform alignment betweenthe native scalp and the transplanted hair will also occur.

More particularly, the donor site hair is partially shaved to preparefor location or placement of the perforated plate on the scalp. Theperforated plate is positioned on the occipital scalp donor site toprovide a maximum harvest. FIG. 30 shows placement of the perforatedplate on the occipital scalp donor site, under an embodiment. Massharvesting of hair plugs is achieved using the spring-loaded pixilationdevice comprising the impact punch hand-piece with a scalpet disposabletip. An embodiment is configured for harvesting of individual hair plugsusing off-the-shelf FUE extraction devices or biopsy punches; the holesin the perforated plates supplied are sized to accommodate off-the-shelftechnology.

The scalpets comprising the scalpet array disposable tip are configuredto penetrate down to the subcutaneous fat later to capture the hairfollicle. FIG. 31 shows scalpet penetration depth through skin when thescalpet is configured to penetrate to the subcutaneous fat layer tocapture the hair follicle, under an embodiment. Once the hair plugs areincised, they are harvested onto an adhesive membrane by transecting thebase of the hair plug with the transection blade, but are not solimited. FIG. 32 shows hair plug harvesting using the perforated plateat the occipital donor site, under an embodiment. The original alignmentof the hair plugs with respect to each other is maintained by applyingan adherent membrane of an embodiment. The adherent membrane is appliedbefore transecting the base of the resected pixels, the embodiments arenot so limited. The aligned matrix of hair plugs on the adherentmembrane is subsequently grafted en masse to a recipient site on thefrontal-parietal scalp.

Additional single hair plugs may be harvested through the perforatedplate, to be used to create the visible hairline, for example. FIG. 33shows creation of the visible hairline, under an embodiment. The visiblehairline is determined and developed with a manual FUT technique. Thevisible hairline and the mass transplant of the vertex may be performedconcurrently or as separate stages. If the visible hairline and masstransplant are performed concurrently, the recipient site is developedstarting with the visible hairline.

Transplantation of harvested hair plugs comprises preparing therecipient site is prepared by resecting non-hair bearing skin plugs in atopographically identical pattern as the pattern of the harvestedoccipital scalp donor site. FIG. 34 shows preparation of the donor siteusing the patterned perforated plate and spring-loaded pixilation deviceto create identical skin defects at the recipient site, under anembodiment. The recipient site of an embodiment is prepared for the masstransplant of the hair plugs using the same perforated plate andspring-loaded pixilation device that was used at the donor site. Scalpdefects are created at the recipient site. These scalp defects have thesame geometry as the harvested plugs on the adherent membrane.

The adherent membrane carrying the harvested hair plugs is applied overthe same pattern of scalp defects at recipient site. Row-by-row eachfollicle-bearing or hair-bearing skin plug is inserted into its mirrorimage recipient defect. FIG. 35 shows transplantation of harvested plugsby inserting harvested plugs into a corresponding skin defect created atthe recipient site, under an embodiment. Plug-to-plug alignment ismaintained, so the hair that grows from the transplanted hair plugs laysas naturally as it did at the donor site. More uniform alignment betweenthe native scalp and the transplanted hair will also occur.

Clinical endpoints vary from patient to patient, but it is predictedthat a higher percentage of hair plugs will “take” as a result ofimproved neovascularization. FIG. 36 shows a clinical end point usingthe pixel dermatome instrumentation and procedure, under an embodiment.The combination of better “takes”, shorter procedure times, and a morenatural-looking result, enable the pixel dermatome instrumentation andprocedure of an embodiment to overcome the deficiencies in conventionalhair transplant approaches.

Embodiments of pixelated skin grafting for skin defects and pixelatedskin resection for skin laxity are described in detail herein. Theseembodiments remove a field of skin pixels in an area of lax skin whereskin tightening is desired. The skin defects created by this procedure(e.g., in a range of approximately 1.5-3 mm-diameter) are small enoughto heal per primam without visible scarring; the wound closure of themultiple skin defects is performed directionally to produce a desiredcontouring effect. Live animal testing of the pixel resection procedurehas produced excellent results.

The pixel procedure of an embodiment is performed in an office settingunder a local anesthetic but is not so limited. The surgeon uses theinstrumentation of an embodiment to rapidly resect an array of skinpixels (e.g., circular, elliptical, square, etc.). Relatively littlepain is associated with the procedure. The intradermal skin defectsgenerated during the procedure are closed with the application of anadherent Flexan (3M) sheet, but embodiments are not so limited.Functioning as a large butterfly bandage, the Flexan sheet is pulled ina direction that maximizes the aesthetic contouring of the treatmentarea. A compressive elastic garment is then applied over the dressing toassist aesthetic contouring. During recovery, the patient wears asupport garment over the treatment area for a period of time (e.g., 5days, etc.). After initial healing, the multiplicity of small linearscars within the treatment area is not visibly apparent. Additional skintightening will occur subsequently over several months from the delayedwound healing response. Consequently, the pixel procedure is a minimallyinvasive alternative for skin tightening in areas where the extensivescarring of traditional aesthetic plastic surgery is to be avoided.

The pixel procedure evokes cellular and extracellular responses that areobligatory to the clinical outcomes achieved. A physical reduction ofthe skin surface area occurs due to the fractional resection of skin,which physically removes a portion of skin directly in the area oflaxity. In addition, a subsequent tightening of the skin is realizedfrom the delayed wound healing response. Each pixilated resectioninitiates an obligate wound healing sequence. The healing responseeffected in an embodiment comprises three phases, as previouslydescribed in detail herein.

The first phase of this sequence is the inflammatory phase in whichdegranulation of mast cells releases histamine into the “wound”.Histamine release evokes dilatation of the capillary bed and increasesvessel permeability into the extracellular space. This initial woundhealing response occurs within the first day and will be evident aserythema on the skin's surface.

Within days of “wounding”, the second phase of healing, fibroplasia,commences. During fibroplasia, there is migration and mitoticmultiplication of fibroblasts. Fibroplasia has two key features: thedeposition of neocollagen and the myofibroblastic contraction of thewound. Histologically, the deposition of neocollagen is identifiedmicroscopically as compaction and thickening of the dermis. Althoughthis is a static process, the tensile strength of the skin significantlyincreases. Myofibroblastic contraction is a dynamic physical processthat results in two-dimensional tightening of the skin surface. Thisprocess is due to the active cellular contraction of myofibroblasts andthe deposition of contractile proteins within the extracellular matrix.Overall, the effect of fibroplasia will be dermal contraction and thedeposition of a static supporting scaffolding of neocollagen with atightened framework. The clinical effect is realized as a delayedtightening of skin with smoothing of skin texture over some number ofmonths. The clinical endpoint is a more youthful appearing skin envelopeof the treatment area.

A third and final phase of the delayed wound healing response ismaturation. During maturation, there is a strengthening and remodelingof the treatment area due to increased cross-linkage of the collagenfibril matrix (of the dermis). This final stage commences within 6 to 12months after “wounding” and may extend for at least 1-2 years. Smallpixilated resections of skin should preserve the normal dermalarchitecture during maturation, but without the creation of a visuallyevident scar that typically occurs with a larger surgical resection ofskin. Lastly, there is a related stimulation and rejuvenation of theepidermis from the release of epidermal growth hormone.

FIGS. 37-42 show images resulting from a pixel procedure conducted on alive animal, under an embodiment. Embodiments described herein were usedin this proof-of-concept study in an animal model that verified thepixel procedure produces aesthetic skin tightening without visiblescarring. The study used a live porcine model, anesthetized for theprocedure. FIG. 37 is an image of the skin tattooed at the corners andmidpoints of the area to be resected, under an embodiment. The fieldmargins of resection were demarcated with a tattoo for post-operativeassessment, but embodiments are not so limited. The procedure wasperformed using a perforated plate (e.g., 10×10 pixel array) todesignate the area for fractional resection. The fractional resectionwas performed using biopsy punches (e.g., 1.5 mm diameter). FIG. 38 isan image of the post-operative skin resection field, under anembodiment. Following the pixel resection, the pixelated resectiondefects were closed (horizontally) with Flexan membrane.

Eleven days following the procedure, all resections had healed perprimam in the area designated by the tattoo, and photographic anddimensional measurements were made. FIG. 39 is an image at 11 daysfollowing the procedure showing resections healed per primam, withmeasured margins, under an embodiment. Photographic and dimensionalmeasurements were subsequently made 29 days following the procedure.FIG. 40 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured margins, under an embodiment. FIG.41 is an image at 29 days following the procedure showing resectionshealed per primam and maturation of the resection field continuing perprimam, with measured lateral dimensions, under an embodiment.Photographic and dimensional measurements were repeated 90 dayspost-operative, and the test area skin was completely smooth to touch.FIG. 42 is an image at 90 days post-operative showing resections healedper primam and maturation of the resection field continuing per primam,with measured lateral dimensions, under an embodiment.

Fractional resection as described herein is performed intradermally orthrough the entire thickness of the dermis. The ability to incise skinwith a scalpet (e.g., round, square, elliptical, etc.) is enhanced withthe addition of additional force(s). The additional force includes forceapplied to the scalpet or scalpet array, for example, where the forcecomprises one or more of rotational force, kinetic impact force, andvibrational force, all of which are described in detail herein for skinfractional resection.

The scalpet device of an embodiment generally includes a scalpetassembly and a housing. The scalpet assembly includes a scalpet array,which comprises a number of scalpets, and force or drive components. Thescalpet assembly includes one or more alignment plates configured toretain and position the scalpets precisely according to theconfiguration of the scalpet array, and to transmit force (e.g., z-axis)from the operator to the subject tissue targeted for resection. Thescalpet assembly includes spacers configured to retain alignment platesat a fixed distance apart and coaxial with the scalpet array, but is notso limited.

A shell is configured to retain the spacers and the alignment plates,and includes attachment point(s) for the housing and drive shaft. Thealignment plates and/or the spacers are attached or connected (e.g.,snapped, welded (e.g., ultrasonic, laser, etc.), heat-staked, etc.) intoposition in the shell, thereby providing a rigid assembly anddiscourages tampering or re-purposing of the scalpet array.Additionally, the shell protects the drive mechanism or gearing andscalpets from contamination during use and allows lubrication (ifrequired) to be applied to the gearing to reduce the torque requirementand increase the life of the gears.

As an example of the application of force using the embodiments herein,the ability to incise skin with a circular scalpet is enhanced with theaddition of a rotational torque. The downward axial force used to incisethe skin is significantly reduced when applied in combination with arotational force. This enhanced capability is similar to a surgeonincising skin with a standard scalpel where the surgeon uses acombination of movement across the skin (kinetic energy) with thesimultaneous application of compression (axial force) to moreeffectively cut the skin surface.

For piercing the skin, the amount of surface compression required issignificantly reduced if a vertical kinetic force is employedsimultaneously. For example, the use of a dart throwing technique forinjections has been employed by healthcare providers for severaldecades. An “impactor” action imparted on skin by a circular scalpet ofan embodiment enhances this modality's cutting capability bysimultaneously employing axial compressive and axial kinetic forces. Theaxial compressive force used to incise the skin surface is significantlyreduced if applied in combination with kinetic force.

Conventional biopsy punches are intended for a single use application inthe removal of tissue, which is generally achieved by pushing the punchdirectly into the tissue along its central axis. Similarly, thefractional resection of an embodiment uses scalpets comprising acircular configuration. While the scalpets of an embodiment can be usedin a stand-alone configuration, alternative embodiments include scalpetarrays in which scalpets are bundled together in arrays of various sizesconfigured to remove sections of skin, but are not so limited. The forceused to pierce the skin using the fractional resection scalpet is afunction of the number of scalpets in the array, so that as the arraysize increases the force used to pierce the skin increases.

The ability to incise skin with a circular scalpet is significantlyenhanced with a reduction in the force needed to pierce the skinintroduced through the addition of a rotational motion around itscentral axis and/or an impact force along its central axis. FIG. 43 is ascalpet showing the applied rotational and/or impact forces, under anembodiment. This enhanced rotational configuration has an affect similarto a surgeon incising skin with a standard scalpel where the surgeonuses a combination of movement across the skin (kinetic energy) with thesimultaneous application of compression (axial force) to moreeffectively cut the skin surface. The impact force is similar to the useof a staple gun or by quickly moving a hypodermic needle prior toimpacting the skin.

A consideration in the configuration of the scalpet rotation is theamount of torque used to drive multiple scalpets at a preferred speed,because the physical size and power of the system used to drive thescalpet array increases as the required torque increases. To reduce theincisional force required in a scalpet array, rows or columns orsegments of the array may be individually driven or sequentially drivenduring an array application. Approaches for rotating the scalpetsinclude but are not limited to geared, helical, slotted, inner helical,pin driven, and frictional (elastomeric).

The scalpet array configured for fractional resection using combinedrotation and axial incision uses one or more device configurations forrotation. For example, the scalpet array of the device is configured torotate using one or more of geared, external helical, inner helical,slotted, and pin drive rotating or oscillating mechanisms, but is not solimited. Each of the rotation mechanisms used in various embodiments isdescribed in detail herein.

FIG. 44 shows a geared scalpet and an array including geared scalpets,under an embodiment. FIG. 45 is a bottom perspective view of a resectiondevice including the scalpet assembly with geared scalpet array, underan embodiment. The device comprises a housing (depicted as transparentfor clarity of details) configured to include the geared scalpet arrayfor the application of rotational torque for scalpet rotation. FIG. 46is a bottom perspective view of the scalpet assembly with geared scalpetarray (housing not shown), under an embodiment. FIG. 47 is a detailedview of the geared scalpet array, under an embodiment.

The geared scalpet array includes a number of scalpets as appropriate toa resection procedure in which the array is used, and a gear is coupledor connected to each scalpet. For example, the gear is fitted over oraround a scalpet, but the embodiment is not so limited. The gearedscalpets are configured as a unit or array so that each scalpet rotatesin unison with adjacent scalpets. For example, once fit, the gearedscalpets are installed together in alignment plates so that each scalpetengages and rotates in unison with its adjacent four scalpets and isthereby retained in precise alignment. The geared scalpet array isdriven by at least one rotating external shaft carrying a gear at thedistal end, but is not so limited. The rotational shaft(s) is configuredto provide or transmit the axial force, which compresses the scalpets ofthe array into the skin during incision. Alternatively, axial force maybe applied to the plates retaining the scalpets.

In an alternative embodiment, a frictional drive is used to drive orrotate the scalpets of the arrays. FIG. 48 shows an array includingscalpets in a frictional drive configuration, under an embodiment. Thefrictional drive configuration includes an elastomeric ring around eachscalpet, similar to gear placement in the geared embodiment, andfrictional forces between the rings of adjacent scalpets in compressionresults in rotation of the scalpets similar to the geared array.

The resection devices comprise helical scalpet arrays, including but notlimited to external and internal helical scalpet arrays. FIG. 49 shows ahelical scalpet (external) and an array including helical scalpets(external), under an embodiment. FIG. 50 shows side perspective views ofa scalpet assembly including a helical scalpet array (left), and theresection device including the scalpet assembly with helical scalpetarray (right) (housing shown), under an embodiment. FIG. 51 is a sideview of a resection device including the scalpet assembly with helicalscalpet array assembly (housing depicted as transparent for clarity ofdetails), under an embodiment. FIG. 52 is a bottom perspective view of aresection device including the scalpet assembly with helical scalpetarray assembly (housing depicted as transparent for clarity of details),under an embodiment. FIG. 53 is a top perspective view of a resectiondevice including the scalpet assembly with helical scalpet arrayassembly (housing depicted as transparent for clarity of details), underan embodiment.

The helical scalpet configuration comprises a sleeve configured to fitover an end region of the scalpet, and an external region of the sleeveincludes one or more helical threads. Once each scalpet is fitted with asleeve, the sleeved scalpets are configured as a unit or array so thateach scalpet rotates in unison with the adjacent scalpets.Alternatively, the helical thread is formed on or as a component of eachscalpet.

The helical scalpet array is configured to be driven by a push platethat oscillates up and down along a region of the central axis of thescalpet array. FIG. 54 is a push plate of the helical scalpet array,under an embodiment. The push plate includes a number of alignment holescorresponding to a number of scalpets in the array. Each alignment holeincludes a notch configured to mate with the helical (external) threadon the scalpet sleeve. When the push plate is driven it causes rotationof each scalpet in the array. FIG. 55 shows the helical scalpet arraywith the push plate, under an embodiment.

The resection devices further comprise internal helical scalpet arrays.The device comprises a housing configured to include the helical scalpetarray assembly for the application of rotational torque for scalpetrotation. FIG. 56 shows an inner helical scalpet and an array includinginner helical scalpets, under an embodiment. The inner helical scalpetincludes a twisted square rod (e.g., solid, hollow, etc.) or insert thatis fitted into an open end of the scalpet. Alternatively, the scalpet isconfigured to include a helical region. The twisted insert is held inplace by bonding (e.g., crimping, bonding, brazing, welding, gluing,etc.) a portion of the scalpet around the insert. Alternative, theinsert is held in place with an adhesive bond. Inner helical scalpetsare then configured as a unit or array so that each scalpet isconfigured to rotate in unison with the adjacent scalpets. The helicalscalpet array is configured to be driven by a drive plate that moves oroscillates up and down along the helical region of each scalpet of thescalpet array. The drive plate includes a number of square alignmentholes corresponding to a number of scalpets in the array. When the driveplate is driven up and down it causes rotation of each scalpet in thearray. FIG. 57 shows the helical scalpet array with the drive plate,under an embodiment.

FIG. 58 shows a slotted scalpet and an array including slotted scalpets,under an embodiment. The slotted scalpet configuration comprises asleeve configured to fit over an end region of the scalpet, and thesleeve includes one or more spiral slots. Alternatively, each scalpetincludes the spiral slot(s) without use of the sleeve. The sleevedscalpets are configured as a unit or array so that the top region of theslots of each scalpet are aligned adjacent one another. An externaldrive rod is aligned and fitted horizontally along the top of the slots.When the drive rod is driven downward, the result is a rotation of thescalpet array. FIG. 59 shows a portion of a slotted scalpet array (e.g.,four (4) scalpets) with the drive rod, under an embodiment. FIG. 60shows an example slotted scalpet array (e.g., 25 scalpets) with thedrive rod, under an embodiment.

FIG. 61 shows an oscillating pin drive assembly with a scalpet, under anembodiment. The assembly includes a lower plate and a middle platecoupled or connected to the scalpet(s) and configured to retain thescalpet(s). A top plate, or drive plate, is positioned in an area abovethe scalpet and the middle plate, and includes a drive slot or slot. Apin is coupled or connected to a top portion of the scalpet, and a topregion of the pin extends beyond a top of the scalpet. The slot isconfigured to receive and loosely retain the pin. The slot is positionedrelative to the pin such that rotation or oscillation of the top platecauses the scalpet to rotate or oscillate via tracking of the pin in theslot.

The scalpet assembly includes an adjustment for control of the amount ofscalpet exposure from the housing. The variable length scalpet exposureis controlled through adjustments of the scalpet guide plates but is notso limited. FIG. 62 shows variable scalpet exposure control with thescalpet guide plates, under an embodiment. Alternative embodimentscontrol scalpet exposure from within the scalpet array handpiece, and/orunder one or more of software, hardware, and mechanical control.

Embodiments include a mechanical scalpet array in which axial force androtational force are applied manually by the compressive force from thedevice operator. FIG. 63 shows a scalpet assembly including a scalpetarray (e.g., helical) configured to be manually driven by an operator,under an embodiment.

Embodiments include and/or are coupled or connected to a source ofrotation configured to provide optimal rotation (e.g., RPM) androtational torque to incise skin in combination with axial force.Optimal rotation of the scalpets is configured according to the bestbalance between rotational velocity and increased cutting efficiencyversus increased frictional losses. Optimal rotation for each scalpetarray configuration is based on one or more of array size (number ofscalpets), scalpet cutting surface geometry, material selection ofscalpets and alignment plates, gear materials and the use oflubrication, and mechanical properties of the skin, to name a few.

Regarding forces to be considered in configuration of the scalpets andscalpet arrays described herein, FIG. 64 shows forces exerted on ascalpet via application to the skin. The parameters considered indetermining applicable forces under an embodiment include the following:

-   -   Average Scalpet Radius: r    -   Scalpet Rotation Rate: ω    -   Scalpet Axial Force: F_(n) (scalpet applied normal to skin)    -   Skin Friction Coefficient: μ    -   Friction Force: F_(f)    -   Scalpet Torque: τ    -   Motor Power: P_(hp).

Upon initial application, the torque used to rotate the scalpet is afunction of the axial force (applied normally to the surface of theskin) and the coefficient of friction between the scalpet and the skin.This friction force initially acts on the cutting surface of thescalpet. At initial application of scalpet to skin:

F _(f) =μ·F _(n)

τ=F _(f) ·r

P _(hp)=τ·ω/63025

The initial force for the scalpet to penetrate the skin, is a functionof the scalpet sharpness, the axial force, the tensile strength of theskin, the coefficient of friction between the skin and the scalpet.Following penetration of the scalpet into the skin, the friction forceincreases as there are additional friction forces acting on the sidewalls of the scalpet.

Resection devices of embodiments include kinetic impaction incisiondevices and methods for non-rotational piercing of the skin. Approachesfor direct compression of the scalpet into the skin include, but are notlimited to, axial force compression, single axial force compression pluskinetic impact force, and moving of the scalpet at a high velocity toimpact and pierce the skin. FIG. 65 depicts steady axial forcecompression using a scalpet, under an embodiment. Steady axial forcecompression places the scalpet in direct contact with the skin. Once inplace, a continuous and steady axial force is applied to the scalpetuntil it pierces the skin and proceeds through the dermis to thesubcutaneous fat layer.

FIG. 66 depicts steady single axial force compression plus kineticimpact force using a scalpet, under an embodiment. Steady single axialforce compression plus kinetic impact force places the scalpet in directcontact with the skin. An axial force is applied to maintain contact.The distal end of the scalpet is then struck by another object,imparting additional kinetic energy along the central axis. These forcescause the scalpet to pierce the skin and proceed through the dermis tothe subcutaneous fat layer.

FIG. 67 depicts moving of the scalpet at a velocity to impact and piercethe skin, under an embodiment. The scalpet is positioned a shortdistance away from a target area of the skin. A kinetic force is appliedto the scalpet to achieve a desired velocity for piercing the skin. Thekinetic force causes the scalpet to pierce the skin and proceed throughthe dermis to the subcutaneous fat layer.

Scalpets of an embodiment include numerous cutting surface or bladegeometries as appropriate to an incision method of a procedure involvingthe scalpet. The scalpet blade geometries include, for example, straightedge (e.g., cylindrical), beveled, multiple-needle tip (e.g., sawtooth,etc.), and sinusoidal, but are not so limited. As but one example, FIG.68 depicts a multi-needle tip, under an embodiment.

The scalpets include one or more types of square scalpets, for example.The square scalpets include but are not limited to, square scalpetswithout multiple sharpened points, and square scalpets with multiplesharpened points or teeth. FIG. 69 shows a square scalpet without teeth(left), and a square scalpet with multiple teeth (right), under anembodiment.

The fractional resection devices of an embodiment involve the use of asquare scalpet assembled onto a scalpet array that has multiplesharpened points to facilitate skin incising through directnon-rotational kinetic impacting. The square geometry of the harvestedskin plug provides side-to-side and point-to-point approximation of theassembled skin plugs onto the adherent membrane. Closer approximation ofthe skin plugs provides a more uniform appearance of the skin graft atthe recipient site. In addition, each harvested component skin plug willhave additional surface area (e.g., 20-25%).

Further, the scalpets include one or more types of elliptical or roundscalpets. The round scalpets include but are not limited to, roundscalpets with oblique tips, round scalpets without multiple sharpenedpoints or teeth, and round scalpets with multiple sharpened points orteeth. FIG. 70 shows multiple side, front (or back), and sideperspective views of a round scalpet with an oblique tip, under anembodiment. FIG. 71 shows a round scalpet with a serrated edge, under anembodiment.

The resection device of an embodiment is configured to include extrusionpins corresponding to the scalpets. FIG. 72 shows a side view of theresection device including the scalpet assembly with scalpet array andextrusion pins (housing depicted as transparent for clarity of details),under an embodiment. FIG. 73 shows a top perspective cutaway view of theresection device including the scalpet assembly with scalpet array andextrusion pins (housing depicted as transparent for clarity of details),under an embodiment. FIG. 74 shows side and top perspective views of thescalpet assembly including the scalpet array and extrusion pins, underan embodiment.

The extrusion pins of an embodiment are configured to clear retainedskin plugs, for example. The extrusion pins of an alternative embodimentare configured to inject into fractional defects at the recipient site.The extrusion pins of another alternative embodiment are configured toinject skin plugs into pixel canisters of a docking station forfractional skin grafting.

Embodiments herein include the use of a vibration component or system tofacilitate skin incising with rotation torque/axial force and to usevibration to facilitate skin incising with direct impaction withoutrotation. FIG. 75 is a side view of a resection device including thescalpet assembly with scalpet array assembly coupled to a vibrationsource, under an embodiment.

Embodiments herein include an electro-mechanical scalpet arraygenerator. FIG. 76 shows a scalpet array driven by an electromechanicalsource or scalpet array generator, under an embodiment. The function ofthe generator is powered but is not electronically controlled, butembodiments are not so limited. The platform of an embodiment includescontrol software.

Embodiments include and/or are coupled or connected to a supplementaryenergy or force configured to reduce the axial force used to incise skin(or another tissue surface such as mucosa) by a scalpet in a scalpetarray. Supplemental energies and forces include one or more ofrotational torque, rotational kinetic energy of rotation (RPM),vibration, ultrasound, and electromagnetic energy (e.g., RF, etc.), butare not so limited.

Embodiments herein include a scalpet array generator comprising and/orcoupled to an electromagnetic radiation source. The electromagneticradiation source includes, for example, one or more of a Radio Frequency(RF) source, a laser source, and an ultrasound source. Theelectromagnetic radiation is provided to assist cutting with thescalpets.

Embodiments include a scalpet mechanism configured as a “sewing machine”scalpet or scalpet array in which the scalpets are repeatedly retractedand deployed under one or more of manual, electromechanical, andelectronic control. This embodiment includes a moving scalpet or scalpetarray to resect a site row-by-row. The resection can, for example takethe form of a stamping approach where the scalpet or scalpet arraymoves, or the array could be rolled over the surface to be treated andthe scalpet array resection at given distances traveled to achieve thedesired resection density.

The fractional resection devices described herein are configured forfractional resection and grafting in which the harvesting offractionally incised skin plugs is performed with a vacuum that depositsthe plugs within the lumen of each scalpet shaft. The skin plugs arethen inserted into a separate docking station described herein by aproximal pin array that extrudes the skin plug from within the shaft ofthe scalpet.

FIG. 77 is a diagram of the resection device including a vacuum system,under an embodiment. The vacuum system comprises vacuum tubing and avacuum port on/in the device housing, configured to generate a vacuumwithin the housing by drawing air out of the housing. The vacuum of anembodiment is configured to provide vacuum stenting/fixturing of theskin for scalpet incising, thereby providing improved depth control andcutting efficiency.

The vacuum of an alternative embodiment is configured for vacuumevacuation or harvesting of skin plugs and/or hair plugs through one ormore of a scalpet lumen and an array manifold housing. FIG. 78 shows avacuum manifold applied to a target skin surface to evacuate/harvestexcised skin/hair plugs, under an embodiment. The vacuum manifold, whichis configured for direct application onto a skin surface, is coupled orconnected to a vacuum source. FIG. 79 shows a vacuum manifold with anintegrated wire mesh applied to a target skin surface toevacuate/harvest excised skin/hair plugs, under an embodiment.

Additionally, an external vacuum manifold is used with asuction-assisted lipectomy machine to percutaneously evacuatesuperficial sub-dermal fat through fractionally resection skin defectsin a fractionally created field for the treatment of cellulite. FIG. 80shows a vacuum manifold with an integrated wire mesh configured tovacuum subdermal fat, under an embodiment.

The external vacuum manifold can also be configured to include and bedeployed with an incorporated docking station (described herein) toharvest skin plugs for grafting. The docking station can be one or moreof static, expandable, and/or collapsible.

The fractional resection devices described herein comprise a separatedocking station configured as a platform to assemble the fractionallyharvested skin plugs into a more uniform sheet of skin for skingrafting. The docking station includes a perforated grid matrixcomprising the same pattern and density of perforations as the scalpetson the scalpet array. A holding canister positioned subjacent to eachperforation is configured to retain and maintain alignment of theharvested skin plug. In an embodiment, the epidermal surface is upwardat the level of the perforation. In an alternative embodiment, thedocking station is partially collapsible to bring docked skin plugs intocloser approximation prior to capture onto an adherent membrane. Thecaptured fractional skin graft on the adherent membrane is then defattedwith either an incorporated or non-incorporated transection blade. Inanother alternative embodiment, the adherent membrane itself has anelastic recoil property that brings or positions the captured skin plugsinto closed alignment. Regardless of embodiment, the contractedfractional skin graft/adherent membrane composite is then directlyapplied to the recipient site defect.

Embodiments include a collapsible docking station or tray configured toaccept and maintain orientation of harvested skin and/or hair plugs oncethey have been removed or ejected from the scalpets via the extrusionpins. FIG. 81 depicts a collapsible docking station and an inserted skinpixel, under an embodiment. The docking station is formed fromelastomeric material but is not so limited. The docking station isconfigured for stretching from a first shape to a second shape thataligns the pixel receptacles with the scalpet array on the handpiece.FIG. 82 is a top view of a docking station (e.g., elastomeric) instretched (left) and un-stretched (right) configuration, under anembodiment, under an embodiment.

The pixels are ejected from the scalpet array into the docking stationuntil it is full, and the docking station is then relaxed to itspre-stretched shape, which has the effect of bringing the pixels incloser proximity to each other. A flexible semi-permeable membrane withadhesive on one side is then stretched and placed over the dockingstation (adhesive side down). Once the pixels are adhered to themembrane, it is lifted away from the docking station. The membrane thenreturns to its normal un-stretched state, which also has the effect ofpulling the pixels closer to each other. The membrane is then placedover the recipient defect.

Resection devices described herein include delivery of therapeuticagents through resectioned defects generated with the resection devicesdescribed herein. As such, the resection sites are configured for use astopically applied infusion sites for delivery or application oftherapeutic agents for the reduction of fat cells (lipolysis) during orafter a resectioning procedure.

Embodiments herein are configured for hair transplantation that includesvacuum harvesting of hair plugs into the scalpet at the donor site, anddirect mass injection (without a separate collection reservoir) ofharvested hair plugs into the fractionally resected defects of therecipient site. Under this embodiment, the donor scalpet array deployedat the occipital scalp comprises scalpets having a relatively largerdiameter than the constituent scalpets of the scalpet array deployed togenerate defects at the recipient site. Following harvesting of hairplugs at the donor site, the defects generated at the recipient site areplugged using the harvested hair plugs transferred in the scalpet array.

Due to the elastic retraction of the incised dermis, the elasticallyretracted diameter of the hair plug harvested at the occipital scalpwill be similar to the elastically retracted diameter of thefractionally resected defect of the recipient site at thefrontal-parietal-occipital scalp. In an embodiment, hair plugs harvestedwithin the donor scalpet array are extruded directly with proximal pinsin the lumen of the scalpet into a same pattern of fractionally defectscreated by the recipient site scalpet array. The scalpets (containingthe donor hair plugs) of the scalpet array deployed at the donor siteare aligned (e.g., visually) with the same pattern of fractionallyresected field of defects at the recipient scalp site. Upon alignment, aproximal pin within the shaft of each scalpet is advanced down the shaftof the scalpet to extrude the hair plug into the fractionally resecteddefect of the recipient site, thereby effecting a simultaneoustransplantation of multiple hair plugs to the recipient site. This masstransplantation of hair plugs into a fractionally resected recipientsite (e.g., of a balding scalp) is more likely to maintain the hairshaft alignment with other mass transplanted hair plugs of thatrecipient scalp site. Directed closure of the donor site field isperformed in the most clinically effective vector, but is not solimited.

The fractional resection devices described herein are configured fortattoo removal. Many patients later in life desire removal of pigmentedtattoos for a variety of reasons. Generally, removal of a tattooinvolves the removal of the impregnated pigment within the dermis.Conventional tattoo removal approaches have been described from thermalablation of the pigment to direct surgical excision. Thermal ablation bylasers frequently results in depigmentation or area surface scarring.Surgical excision of a tattoo requires the requisite linear scarring ofa surgical procedure. For many patients, the tradeoff between tattooremoval and the sequela of the procedure can be marginal.

The use of fractional resection to remove a tattoo allows for fractionalremoval of a significant proportion of the dermal pigment with minimalvisible scarring. The fractional resection extends beyond the border ofthe tattoo to blend the resection into the non-resected and non-tattooedskin. Most apparently, de-delineation of the pattern of the tattoo willoccur even if all residual pigment is not or cannot be removed. In anembodiment, initial fractional resections are performed with a scalpetarray, and any subsequent fractional resections are performed bysingular scalpet resections for residual dermal pigment. As with otherapplications described herein, directed closure is performed in the mostclinically effective vector.

The fractional resection devices described herein are configured fortreatment of cellulite. This aesthetic deformity has resisted effectivetreatment for several decades as the pathologic mechanism of action ismultifactorial. Cellulite is a combination of age or weight loss skinlaxity with growth and accentuation of the superficial fat loculations.The unsightly cobblestone appearance of the skin is commonly seen in thebuttocks and lateral thighs. Effective treatment should address eachcontributing factor of the deformity.

The fractional resection devices described herein are configured forfractional resection of the skin in order to tighten the affected skinand to simultaneously reduce the prominent fat loculations that arecontributing to the cobblestone surface morphology. Through the samefractionally resected defects created for skin tightening, topicallyapplied vacuum is used to suction the superficial fat loculationspercutaneously. In an embodiment, a clear manifold suction cannula isapplied directly to the fractionally resected skin surface. Theappropriate vacuum pressure used with the suction-assisted lipectomy(SAL) unit is determined by visually gauging that the appropriate amountof sub-dermal fat being suction resected. The appropriate time period ofmanifold application is also a monitored factor in the procedure. Whencombined with fractional skin tightening, only a relatively small amountof fat is suction resected to produce a smoother surface morphology. Aswith other applications described herein, the fractionally resectedfield will be closed with directed closure.

The fractional resection devices described herein are configured forrevision of abdominal striae and scarring. Visually apparent scarring isa deformity that requires clear delineation of the scar from theadjacent normal skin. Delineation of the scar is produced by changes intexture, in pigment and in contour. To make a scar less visiblyapparent, these three components of scarring must be addressed for ascar revision to significantly reduce the visual impact. Severe scarscalled contractures across a joint may also limit the range of motion.For the most part, scar revisions are performed surgically where thescar is elliptically excised and carefully closed by careful coaptationof excised margins of the non-scarred skin. However, any surgicalrevision reintroduces and replaces the pre-existing scar with anincumbent surgical scar that may be also be delineated or only partiallyde-delineated by a Z or W plasty.

Scarring is bifurcated diagnostically into hypertrophic and hypotrophictypes. The hypertrophic scar typically has a raised contour, irregulartexture and is more deeply pigmented. In contrast, the hypotrophic scarhas a depressed contour below the level of the adjacent normal unscarredskin. In addition, the color is paler (depigmented) and the texture issmoother than the normal adjacent skin. Histologically, hypertrophicscars posses an abundance of disorganized dermal scar collagen withhyperactive melanocytes. Hypotrophic scars have a paucity of dermalcollagen with little or no melanocytic activity.

The fractional resection devices described herein are configured forfractional scar revision of a scar that does not reintroduce additionalsurgical scarring but instead significantly de-delineates the visualimpact of the deformity. Instead of a linear surgically induced scar,the fractional resection of the scar results in a net reduction of thepigmentary, textural and contour components. A fractional revision isperformed along the linear dimension of the scar and also extends beyondthe boundary of the scar into the normal skin. The fractional revisionof a scar involves the direct fractional excision of scar tissue withmicro-interlacing of the normal non-scarred skin with the residual scar.Essentially, a micro W-plasty is performed along the entire extent ofthe scar. As with other applications, the fractionally resected field isclosed with directed closure. An example of the use of fractionalrevision includes revising a hypotrophic post-partum abdominal stria.The micro-interlacing of the depressed scar epithelium and dermis of thestria with the adjacent normal skin significantly reduces the depressed,linear and hypo-pigmented appearance of this deformity.

The fractional resection devices described herein are configured forvaginal repair for postpartum laxity and prolapse. The vaginal deliveryof a full term fetus involves in part the massive stretching of thevaginal introitus and vaginal canal. During delivery, elongation of thelongitudinal aspect of the vaginal canal occurs along withcross-sectional dilatation of the labia, vaginal introitus and vaginalvault. For many patients, the birth trauma results in a permanentstretching of the vaginal canal along the longitudinal andcross-sectional aspects. Vaginal repair for prolapse is typicallyperformed as an anterior-posterior resection of vaginal mucosa withinsertion of prosthetic mesh. For patients with severe prolapse, thisprocedure is required as addition support of the anterior and posteriorvaginal wall is needed. However, many patients with post-partum vaginallaxity may be candidates for a less invasive procedure.

The fractional resection devices described herein are configured forfractional resection of the vaginal mucosa circumferentially to narrowthe dilated vaginal canal at the labia and the introitus. The patternfor fractional resection can also be performed in a longitudinaldimension when the vaginal canal is elongated. Directed closure of thefractional field can be assisted with a vacuum tampon that will act asstent to shaped the fractionally resected vaginal canal into apre-partum configuration.

The fractional resection devices described herein are configured fortreatment of snoring and sleep apnea. There are few health implicationsof snoring but the disruptive auditory effect upon the relationship ofsleeping partners can be severe. For the most part, snoring is due tothe dysphonic vibration of intraoral and pharyngeal soft tissuestructures within the oral, pharyngeal and nasal cavities duringinspiration and expiration. More specifically, the vibration of the softpalate, nasal turbinates, lateral pharyngeal walls and base of thetongue are the key anatomic structures causing snoring. Many surgicalprocedures and medical devices have had limited success in amelioratingthe condition. Surgical reductions of the soft palate are frequentlycomplicated with a prolonged and painful recovery due to bacterialcontamination of the incision site.

The fractional resection devices described herein are configured forfractional resection of the oropharyngeal mucosa in order to reduce theage related mucosal redundancy (and laxity) of intraoral and pharyngealsoft tissue structures and not be complicated with prolonged bacterialcontamination of the fractional resection sites. The reduction in sizeand laxity of these structures reduces vibration caused by the passageof air. A perforated (to spray a topical local anesthetic onto thefractional resection field) intraoral dental retainer (that is securedto the teeth and wraps around the posterior aspect of the soft palate)is used to provide directed closure in the anterior-posterior dimensionof the soft palate. A more severe condition called sleep apnea does haveserious health implications due to the hypoxia caused by upper airwayobstruction during sleep. Although CPAP has become a standard for thetreatment of sleep apnea, selective fractional resection of the base ofthe tongue and the lateral pharyngeal walls can significantly reducesleep related upper airway obstruction.

The fractional resection devices described herein are configured forfractional skin culturing/expansion, also referred to herein as“Culturespansion”. The ability to grow skin organotypically would be amajor accomplishment for patients with large skin defects such as burnsand trauma and major congenital skin malformations such port-wine stainsand large ‘bathing trunk’ nevi. Conventional capability is limited toproviding prolonged viability of harvested skin, although some reportshave indicated that wound healing has occurred with organotypic skincultured specimens. It has been reported that enhanced cultured outcomeswill occur with better substrates, cultured media and more effectivefiltration of metabolic byproducts. The use of gene expressionproteinomics for growth hormone and wound healing stimulation is alsopromising. To date however, there is no report that skin has been grownorganotypically.

The fractional harvesting of autologous donor skin for skin graftingunder an embodiment provides an opportunity in the organotypic cultureof skin that did not previously exist. The deposition of a fractionallyharvested skin graft onto a collapsible docking station, as provided bythe embodiments described herein, enables skin plugs to be brought intocontact apposition with each other. The induction of a primary woundhealing process can convert a fractional skin graft into a solid sheetby known or soon to be developed organotypic culture methodology.Further, the use of mechanical skin expansion can also greatly increasethe surface area of the organotypically preserved/grown skin. In vitrosubstrate device iterations include without limitation, an expandabledocking station comprising fractionally harvested skin plugs and aseparate substrate (e.g., curved, flat, etc.) expander that iscontrollable to provide a gradual and continual expansion of the fullthickness organotypically cultured skin. Additionally, the use oforganotypic skin expansion may provide a continual and synergisticwound-healing stimulus for organotypic growth. A gradual and continualexpansion is less likely to delaminate (the basement membrane) theepidermis from the dermis. Additionally, organotypic skin expansionhelps avoid the surgical risk and pain associated in-vivo skinexpansion.

The fractional resection devices described herein enable methods for theorganotypic expansion of skin. The methods comprise an autologousfractional harvest of skin from a donor site of a patient. The use of asquare scalpet array, for example, provides upon transfer side-to-sideand tip-to-tip coaptation of fractionally harvested skin plugs. Themethod comprises transfer of the fractional skin plugs to a collapsibledocking station that maintains orientation and provides apposition ofskin plugs. The docked skin plugs are captured onto a porous adherentmembrane that maintains orientation and apposition. The semi-elasticrecoil property of the adherent membrane provides additional contact andapposition of skin plugs. The method includes transfer of the adherentmembrane/fractional graft composite to a culture bay comprising asubstrate and a culture media that retains viability and promotesorganotypic wound healing and growth. Following healing of skin plugmargins, the entire substrate is placed into a culture bath that has amechanical expander substrate. Organotypic expansion is then initiatedin a gradual and continuous fashion. The expanded full thickness skin isthen autologously grafted to the patient's recipient site defect.

Organotypic skin expansion can be performed on non-fractional skingrafts or more generally, on any other tissue structure as organotypicexpansion. The use of mechanical stimulation to evoke a wound healingresponse for organotypic culture can also be an effective adjunct.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly. The scalpet assembly comprisesa scalpet array and at least one guide plate. The scalpet array includesa plurality of scalpets. At least one guide plate maintains aconfiguration of the plurality of scalpets. The scalpet array isconfigured to be deployed from and retracted into the housing. Thescalpet array is configured to generate a plurality of incised skinpixels at a target site when deployed. A drive system coupled to thescalpet array and configured to couple a force to the scalpet array forthe generation of the plurality of incised skin pixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly; the scalpet assemblycomprising a scalpet array and at least one guide plate, wherein thescalpet array includes a plurality of scalpets, wherein the at least oneguide plate maintains a configuration of the plurality of scalpets,wherein the scalpet array is configured to be deployed from andretracted into the housing, wherein the scalpet array is configured togenerate a plurality of incised skin pixels at a target site whendeployed; a drive system coupled to the scalpet array and configured tocouple a force to the scalpet array for the generation of the pluralityof incised skin pixels.

The drive system is configured to apply rotational force to the scalpetarray, wherein the rotational force is configured to rotate at least aset of the plurality of scalpets.

The drive system comprises a geared drive system.

The geared drive system comprises a gear component configured to bedriven to deliver a rotational force to the scalpet array.

The gear component includes a gear.

Each scalpet is coupled to the gear.

Each scalpet comprises the gear.

The drive system comprises a frictional drive system.

The frictional drive system is configured to generate frictional forcesthrough a compressive component of at least a set of the plurality ofscalpets, wherein the frictional forces are configured to rotate atleast a set of the plurality of scalpets.

The compressive component includes an elastomeric ring.

Each scalpet is coupled to the elastomeric ring.

Each scalpet comprises the elastomeric ring.

The drive system comprises a helical drive system.

The helical drive system comprises a push plate configured for up anddown movement relative to the scalpet array.

The push plate comprises a plurality of openings configured to align theplurality of scalpets, wherein at least one opening of the plurality ofopenings includes a notch configured to receive a helical component ofat least one scalpet.

The helical component includes an external thread.

A scalpet is coupled to a sleeve comprising the helical component.

A scalpet comprises the helical component.

The drive system comprises a slotted drive system.

The slotted drive system comprises a drive rod configured to couple witha slotted component of the scalpet array, wherein the drive rod isconfigured for up and down movement relative to the scalpet array.

The slotted component includes a slot configured to receive the driverod.

Each scalpet comprises the slot.

Each scalpet comprises a sleeve, and the sleeve comprises the slot.

The drive system comprises an inner helical drive system.

The inner helical drive system comprises a push plate configured for upand down movement relative to the scalpet array.

The push plate comprises a plurality of openings configured to align theplurality of scalpets, wherein at least one opening of the plurality ofopenings is configured to receive a helical component of at least onescalpet.

The helical component includes a threaded insert.

A scalpet is configured to receive the helical component.

A scalpet comprises the helical component.

The scalpet assembly is configured to transmit an axial force to thetarget site.

The axial force comprises a continuous axial force.

The axial force comprises a continuous axial force and an impact force.

The axial force comprises an impact force.

At least one scalpet of the scalpet array comprises a cylindricalscalpet including a cutting surface on a distal end of the scalpet.

The cutting surface includes a sharpened edge.

The cutting surface includes at least one sharpened point.

The cutting surface includes a serrated edge.

The cutting surface includes at least one radius of curvature.

At least one scalpet of the scalpet array comprises a rectangularscalpet including a cutting surface on a distal end of the scalpet.

The cutting surface includes a sharpened edge.

The cutting surface includes at least one sharpened point.

The cutting surface includes a serrated edge.

At least one scalpet of the scalpet array comprises a through orifice.

The system comprises an extrusion system configured to include aplurality of extrusion pins.

The plurality of extrusion pins corresponds to the plurality ofscalpets.

Each extrusion pin is aligned with a corresponding scalpet of theplurality of scalpets.

The plurality of extrusion pins is configured to clear the plurality ofincised skin plugs from an interior of the plurality of scalpets.

The plurality of extrusion pins is configured to inject the plurality ofincised skin plugs into a fractional defect at a recipient site.

The plurality of extrusion pins is configured to inject the plurality ofincised skin plugs into pixel canisters of a docking station.

The extrusion system includes an ejector component coupled to theplurality of extrusion pins, wherein the ejector component is configuredto control movement of the plurality of extrusion pins into and out ofan interior region of the plurality of scalpets.

The system comprises a docking station including a plurality of pixelreceptacles, wherein the docking station is configured to receive theplurality of incised skin plugs removed from the target site.

The docking station is configured to maintain orientation of theplurality of incised skin plugs removed from the target site.

The docking station is configured to be reshaped between a firstconfiguration and a second configuration, wherein the secondconfiguration aligns the plurality of pixel receptacles with theplurality of scalpets of the scalpet array.

The first configuration places the plurality of pixel receptacles inrelatively closer proximity than the second configuration.

The docking station comprises an elastomeric material.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels from the docking station.

The adherent substrate is configured to maintain relative positioning ofthe plurality of incised skin pixels during transfer to and applicationat a recipient site.

The adherent substrate is configured to apply the incised skin pixels tothe skin defects at the recipient site.

The adherent substrate is configured to align the incised skin pixelswith the skin defects at the recipient site.

The adherent substrate is configured to insert each incised skin pixelinto a corresponding skin defect at the recipient site.

The system comprises a vibration system coupled to the scalpet array.

The vibration system is configured to couple vibratory force to thescalpet array.

The system comprises an electromagnetic system coupled to the scalpetarray.

The electromagnetic system is configured to couple electromagneticenergy to the scalpet array, wherein the electromagnetic energy includesat least one of radio frequency (RF) energy, laser energy, andultrasonic energy.

The at least one guide plate includes a plurality of guide plates.

The system comprises a plurality of spacers configured to control andmaintain a distance between the plurality of guide plates.

At least one guide plate is configured to establish the configuration ofthe plurality of scalpets.

At least one guide plate is configured to transfer the force to thetarget site.

A position of the plurality of scalpets is configured to be adjustable,wherein the adjustable position controls a depth of insertion of theplurality of scalpets at the target site when the scalpet array isdeployed.

At least one guide plate is configured for use in the adjustment of theposition of the plurality of scalpets.

The system comprises a vacuum system coupled to the housing, wherein thevacuum system generates a vacuum at the target site, wherein the vacuumcomprises pressure relatively lower than ambient air pressure.

The scalpet array is configured to maintain the vacuum at the targetsite.

The vacuum is configured to evacuate the incised skin pixels from thetarget site via the plurality of scalpets.

The housing is configured to maintain the vacuum at the target site.

The vacuum is configured to evacuate the incised skin pixels from thetarget site via the housing.

The system comprises a vacuum component.

The vacuum component is configured to evacuate the incised skin pixelsfrom the target site.

The vacuum component is configured to evacuate subdermal fat via voidsgenerated at the target site from the incised skin pixels.

The vacuum component includes a vacuum manifold coupled to a vacuumsource.

The drive system comprises an oscillating drive system configured tooscillate at least one scalpet of the scalpet array.

The oscillating drive system comprises a drive plate configured tooscillate between two positions.

The oscillating drive system comprises a drive pin having a distal endconfigured to couple with the at least one scalpet.

The drive plate includes at least one of an orifice and a slotconfigured to receive a proximal end of the drive pin.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels.

The adherent substrate comprises at least one of a flexible substrateand a semi-porous membrane.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The skin defects are configured to evoke neovascularization in theincised skin pixels inserted at the recipient site.

The skin defects are configured to evoke a wound healing response in theincised skin pixels inserted at the recipient site.

The target site includes a donor site, wherein the plurality of incisedskin pixels is harvested at the donor site.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The adherent substrate is configured to maintain relative positioning ofthe plurality of incised skin pixels during transfer to and applicationat the recipient site.

The adherent substrate is configured to apply the incised skin pixels tothe skin defects at the recipient site.

The adherent substrate is configured to align the incised skin pixelswith the skin defects at the recipient site.

The adherent substrate is configured to insert each incised skin pixelinto a corresponding skin defect at the recipient site.

The system comprises at least one bandage configured for application atthe target site.

The at least one bandage is configured to apply force to close thetarget site.

The at least one bandage is configured to apply directional force tocontrol a direction of the closure at the target site.

The system comprises a cutting member configured to transect the incisedskin pixels.

The system comprises an adherent substrate configured to capture theincised skin pixels.

The incised skin pixels include hair follicles.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly. The scalpet assembly comprisesa scalpet array and a guide plate. The scalpet array includes a set ofscalpets. The guide plate maintains a configuration of the set ofscalpets. The scalpet array is configured to be deployed from andretracted into the housing. The scalpet array is configured to generateincised skin pixels at a target site when deployed. The system includesa drive system coupled to the scalpet array and configured to couple aforce to the scalpet array.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly; the scalpet assemblycomprising a scalpet array and a guide plate, wherein the scalpet arrayincludes a set of scalpets, wherein the guide plate maintains aconfiguration of the set of scalpets, wherein the scalpet array isconfigured to be deployed from and retracted into the housing, whereinthe scalpet array is configured to generate incised skin pixels at atarget site when deployed; and a drive system coupled to the scalpetarray and configured to couple a force to the scalpet array.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly. The scalpet assembly comprisesa scalpet array and an extrusion array. The scalpet array includes aplurality of scalpets and at least one guide plate configured toestablish an alignment of the plurality of scalpets. The scalpet arrayis configured to be deployed from the housing to generate a plurality ofincised skin pixels at a target site. The extrusion array includes aplurality of extrusion pins corresponding to and aligned relative to theplurality of scalpets. The plurality of extrusion pins is configured tobe inserted into and clear an interior of the plurality of scalpets.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly; the scalpet assemblycomprising a scalpet array and an extrusion array, wherein the scalpetarray includes a plurality of scalpets and at least one guide plateconfigured to establish an alignment of the plurality of scalpets,wherein the scalpet array is configured to be deployed from the housingto generate a plurality of incised skin pixels at a target site, whereinthe extrusion array includes a plurality of extrusion pins correspondingto and aligned relative to the plurality of scalpets, wherein theplurality of extrusion pins are configured to be inserted into and clearan interior of the plurality of scalpets.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly. The scalpet assembly comprisesa scalpet array and an extrusion array. The scalpet array includes aplurality of scalpets and at least one guide plate configured toestablish an alignment of the plurality of scalpets. The scalpet arrayis configured to be deployed from the housing to generate a plurality ofincised skin pixels at a target site. The extrusion array includes aplurality of extrusion pins corresponding to and aligned relative to theplurality of scalpets. The plurality of extrusion pins is configured tobe inserted into and clear an interior of the plurality of scalpets. Thesystem includes a drive system coupled to the scalpet array andconfigured to couple a force to the scalpet array for the generation ofthe plurality of incised skin pixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly. The scalpet assembly comprisesa scalpet array and an extrusion array. The scalpet array includes aplurality of scalpets and at least one guide plate configured toestablish an alignment of the plurality of scalpets. The scalpet arrayis configured to be deployed from the housing to generate a plurality ofincised skin pixels at a target site. The extrusion array includes aplurality of extrusion pins corresponding to and aligned relative to theplurality of scalpets. The plurality of extrusion pins is configured tobe inserted into and clear an interior of the plurality of scalpets. Thesystem includes a drive system coupled to the scalpet array andconfigured to couple a force to the scalpet array for the generation ofthe plurality of incised skin pixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly; the scalpet assemblycomprising a scalpet array and an extrusion array, wherein the scalpetarray includes a plurality of scalpets and at least one guide plateconfigured to establish an alignment of the plurality of scalpets,wherein the scalpet array is configured to be deployed from the housingto generate a plurality of incised skin pixels at a target site, whereinthe extrusion array includes a plurality of extrusion pins correspondingto and aligned relative to the plurality of scalpets, wherein theplurality of extrusion pins are configured to be inserted into and clearan interior of the plurality of scalpets; a drive system coupled to thescalpet array and configured to couple a force to the scalpet array forthe generation of the plurality of incised skin pixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly. The scalpet assembly comprisesa scalpet array and a guide plate. The scalpet array includes a set ofscalpets. The guide plate maintains a configuration of the set ofscalpets. The scalpet array is configured to be deployed from andretracted into the housing at each target site of a plurality of targetsites. The scalpet array is configured to generate incised skin pixelsat each target site when deployed. The system includes a drive systemcoupled to the scalpet array. The drive system is configured to couple aforce to the scalpet array for the generation of the incised skinpixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly; the scalpet assemblycomprising a scalpet array and a guide plate, wherein the scalpet arrayincludes a set of scalpets, wherein the guide plate maintains aconfiguration of the set of scalpets, wherein the scalpet array isconfigured to be deployed from and retracted into the housing at eachtarget site of a plurality of target sites, wherein the scalpet array isconfigured to generate incised skin pixels at each target site whendeployed; a drive system coupled to the scalpet array, wherein the drivesystem is configured to couple a force to the scalpet array for thegeneration of the incised skin pixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly. The scalpet assembly comprisesa scalpet array and at least one guide plate. The scalpet array includesa plurality of scalpets. At least one guide plate maintains aconfiguration of the plurality of scalpets. Each scalpet of the scalpetarray is configured to be separately deployed from and retracted intothe housing in succession. Deployment of the plurality of scalpets isconfigured to generate a plurality of incised skin pixels at a targetsite. The system includes a drive system coupled to the scalpet arrayand configured to couple a force to the scalpet array for the generationof the plurality of incised skin pixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly; the scalpet assemblycomprising a scalpet array and at least one guide plate, wherein thescalpet array includes a plurality of scalpets, wherein the at least oneguide plate maintains a configuration of the plurality of scalpets,wherein each scalpet of the scalpet array is configured to be separatelydeployed from and retracted into the housing in succession, whereindeployment of the plurality of scalpets is configured to generate aplurality of incised skin pixels at a target site; a drive systemcoupled to the scalpet array and configured to couple a force to thescalpet array for the generation of the plurality of incised skinpixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly. The scalpet assembly comprisesa scalpet array and at least one guide plate. The scalpet array includesa set of scalpets. At least one guide plate maintains a configuration ofthe set of scalpets. Each scalpet of the scalpet array is configured tobe separately deployed from and retracted into the housing insuccession. Deployment of the plurality of scalpets is configured togenerate a plurality of incised skin pixels at a target site. The systemincludes a drive system coupled to the scalpet array and configured tocouple a force to the scalpet array for the generation of the pluralityof incised skin pixels.

Embodiments described herein include a system comprising a housingconfigured to include a scalpet assembly; the scalpet assemblycomprising a scalpet array and at least one guide plate, wherein thescalpet array includes a set of scalpets, wherein the at least one guideplate maintains a configuration of the set of scalpets, wherein eachscalpet of the scalpet array is configured to be separately deployedfrom and retracted into the housing in succession, wherein deployment ofthe plurality of scalpets is configured to generate a plurality ofincised skin pixels at a target site; a drive system coupled to thescalpet array and configured to couple a force to the scalpet array forthe generation of the plurality of incised skin pixels.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly. The scalpetassembly includes a scalpet array and at least one guide plate. Thescalpet array includes a plurality of scalpets. At least one guide platemaintains a configuration of the plurality of scalpets. The methodincludes deploying the scalpet array from the housing into tissue at thetarget site and generating a plurality of incised skin pixels at thetarget site when deployed. The deploying includes coupling a force of adrive system of the scalpet assembly to the scalpet array. The methodincludes retracting the scalpet array into the housing from the targetsite.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly, wherein thescalpet assembly includes a scalpet array and at least one guide plate,wherein the scalpet array includes a plurality of scalpets, wherein theat least one guide plate maintains a configuration of the plurality ofscalpets; deploying the scalpet array from the housing into tissue atthe target site and generating a plurality of incised skin pixels at thetarget site when deployed, wherein the deploying includes coupling aforce of a drive system of the scalpet assembly to the scalpet array;retracting the scalpet array into the housing from the target site. Thedrive system is configured to apply rotational force to the scalpetarray, wherein the rotational force is configured to rotate at least aset of the plurality of scalpets.

The drive system comprises a geared drive system.

The geared drive system comprises a gear component driven to deliver arotational force to the scalpet array.

The gear component includes a gear.

Each scalpet is coupled to the gear.

Each scalpet comprises the gear.

The drive system comprises a frictional drive system.

The frictional drive system generates frictional forces through acompressive component of at least a set of the plurality of scalpets,wherein the frictional forces rotate at least a set of the plurality ofscalpets.

The compressive component includes an elastomeric ring.

Each scalpet is coupled to the elastomeric ring.

Each scalpet comprises the elastomeric ring.

The drive system comprises a helical drive system.

The helical drive system comprises a push plate moving up and downrelative to the scalpet array.

The push plate comprises a plurality of openings aligning the pluralityof scalpets, wherein at least one opening of the plurality of openingsincludes a notch receiving a helical component of at least one scalpet.

The helical component includes an external thread.

A scalpet is coupled to a sleeve comprising the helical component.

A scalpet comprises the helical component.

The drive system comprises a slotted drive system.

The slotted drive system comprises a drive rod coupling with a slottedcomponent of the scalpet array and moving scalpet array up and down.

The slotted component includes a slot receiving the drive rod.

Each scalpet comprises the slot.

Each scalpet comprises a sleeve, and the sleeve comprises the slot.

The drive system comprises an inner helical drive system.

The inner helical drive system comprises a push plate moving up and downrelative to the scalpet array.

The push plate comprises a plurality of openings aligning the pluralityof scalpets, wherein at least one opening of the plurality of openingsreceives a helical component of at least one scalpet.

The helical component includes a threaded insert.

A scalpet receives the helical component.

A scalpet comprises the helical component.

The scalpet assembly transmits an axial force to the target site.

The axial force comprises a continuous axial force.

The axial force comprises a continuous axial force and an impact force.

The axial force comprises an impact force.

At least one scalpet of the scalpet array comprises a cylindricalscalpet including a cutting surface on a distal end of the scalpet.

The cutting surface includes a sharpened edge.

The cutting surface includes at least one sharpened point.

The cutting surface includes a serrated edge.

The cutting surface includes at least one radius of curvature.

At least one scalpet of the scalpet array comprises a rectangularscalpet including a cutting surface on a distal end of the scalpet.

The cutting surface includes a sharpened edge.

The cutting surface includes at least one sharpened point.

The cutting surface includes a serrated edge.

At least one scalpet of the scalpet array comprises a through orifice.

The method comprises an extrusion system configured to include aplurality of extrusion pins.

The plurality of extrusion pins corresponds to the plurality ofscalpets.

Each extrusion pin is aligned with a corresponding scalpet of theplurality of scalpets.

The plurality of extrusion pins clears the plurality of incised skinplugs from an interior of the plurality of scalpets.

The plurality of extrusion pins injects the plurality of incised skinplugs into a fractional defect at a recipient site.

The plurality of extrusion pins injects the plurality of incised skinplugs into pixel canisters of a docking station.

The extrusion system includes an ejector component coupled to theplurality of extrusion pins, wherein the ejector component controlsmovement of the plurality of extrusion pins into and out of an interiorregion of the plurality of scalpets.

The method comprises a docking station including a plurality of pixelreceptacles, wherein the docking station receives the plurality ofincised skin plugs removed from the target site.

The docking station maintains orientation of the plurality of incisedskin plugs removed from the target site.

The docking station is reshaped between a first configuration and asecond configuration, wherein the second configuration aligns theplurality of pixel receptacles with the plurality of scalpets of thescalpet array.

The first configuration places the plurality of pixel receptacles inrelatively closer proximity than the second configuration.

The docking station comprises an elastomeric material.

An adherent substrate capturing the plurality of incised skin pixelsfrom the docking station.

The adherent substrate maintains relative positioning of the pluralityof incised skin pixels during transfer to and application at a recipientsite.

The adherent substrate applies the incised skin pixels to the skindefects at the recipient site.

The adherent substrate aligns the incised skin pixels with the skindefects at the recipient site.

The adherent substrate inserts each incised skin pixel into acorresponding skin defect at the recipient site.

The method comprises a vibration system coupled to the scalpet array.

The vibration system couples vibratory force to the scalpet array.

The method comprises an electromagnetic system coupled to the scalpetarray.

The electromagnetic system couples electromagnetic energy to the scalpetarray, wherein the electromagnetic energy includes at least one of radiofrequency (RF) energy, laser energy, and ultrasonic energy.

The at least one guide plate includes a plurality of guide plates.

The method comprises a plurality of spacers controlling and maintaininga distance between the plurality of guide plates.

The at least one guide plate establishes the configuration of theplurality of scalpets.

The at least one guide plate transfers the force to the target site.

The method comprises adjusting a position of the plurality of scalpets,wherein the adjustable position controls a depth of insertion of theplurality of scalpets at the target site when the scalpet array isdeployed.

The method comprises using the at least one guide plate in theadjustment of the position of the plurality of scalpets.

The method comprises a vacuum system coupled to the housing, wherein thevacuum system generates a vacuum at the target site, wherein the vacuumcomprises pressure relatively lower than ambient air pressure.

The scalpet array maintains the vacuum at the target site.

The vacuum evacuates the incised skin pixels from the target site viathe plurality of scalpets.

The housing maintains the vacuum at the target site.

The vacuum evacuates the incised skin pixels from the target site viathe housing.

The method comprises a vacuum component.

The vacuum component evacuates the incised skin pixels from the targetsite.

The vacuum component evacuates subdermal fat via voids generated at thetarget site from the incised skin pixels.

The vacuum component includes a vacuum manifold coupled to a vacuumsource.

The drive system comprises an oscillating drive system oscillating atleast one scalpet of the scalpet array.

The oscillating drive system comprises a drive plate oscillating betweentwo positions.

The oscillating drive system comprises a drive pin having a distal endcoupling with the at least one scalpet.

The drive plate includes at least one of an orifice and a slot receivinga proximal end of the drive pin.

The method comprises an adherent substrate capturing the plurality ofincised skin pixels.

The adherent substrate comprises at least one of a flexible substrateand a semi-porous membrane.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The skin defects evoke neovascularization in the incised skin pixelsinserted at the recipient site.

The skin defects evoke a wound healing response in the incised skinpixels inserted at the recipient site.

The target site includes a donor site, wherein the plurality of incisedskin pixels is harvested at the donor site.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The method comprises an adherent substrate capturing the plurality ofincised skin pixels at the donor site and transferring the plurality ofincised skin pixels to the recipient site.

The adherent substrate maintains relative positioning of the pluralityof incised skin pixels during transfer to and application at therecipient site.

The adherent substrate applies the incised skin pixels to the skindefects at the recipient site.

The adherent substrate aligns the incised skin pixels with the skindefects at the recipient site.

The adherent substrate inserts each incised skin pixel into acorresponding skin defect at the recipient site.

The method comprises applying at least one bandage at the target site.

The at least one bandage applies force to close the target site.

The at least one bandage applies directional force to control adirection of the closure at the target site.

The method comprises a cutting member transecting the incised skinpixels.

The method comprises an adherent substrate capturing the incised skinpixels.

The incised skin pixels include hair follicles.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly. The scalpetassembly includes a scalpet array and a guide plate. The scalpet arrayincludes a set of scalpets. The guide plate maintains a configuration ofthe set of scalpets. The method includes deploying the scalpet arrayfrom the housing into tissue at the target site and generating incisedskin pixels at a target site when deployed. The deploying includescoupling a force of a drive system of the scalpet assembly to thescalpet array. The method includes retracting the scalpet array into thehousing from the target site.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly, wherein thescalpet assembly includes a scalpet array and a guide plate, wherein thescalpet array includes a set of scalpets, wherein the guide platemaintains a configuration of the set of scalpets; deploying the scalpetarray from the housing into tissue at the target site and generatingincised skin pixels at a target site when deployed, wherein thedeploying includes coupling a force of a drive system of the scalpetassembly to the scalpet array; retracting the scalpet array into thehousing from the target site.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly. The scalpetassembly includes a scalpet array and an extrusion array. The scalpetarray includes a plurality of scalpets and at least one guide plateconfigured to establish an alignment of the plurality of scalpets. Theextrusion array includes a plurality of extrusion pins corresponding toand aligned relative to the plurality of scalpets. The method includesdeploying the scalpet array from the housing into tissue at the targetsite and generating a plurality of incised skin pixels at the targetsite when deployed. The method includes retracting the scalpet arrayinto the housing from the target site. The method includes inserting theplurality of extrusion pins into and clearing an interior of theplurality of scalpets.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly, wherein thescalpet assembly includes a scalpet array and an extrusion array,wherein the scalpet array includes a plurality of scalpets and at leastone guide plate configured to establish an alignment of the plurality ofscalpets, wherein the extrusion array includes a plurality of extrusionpins corresponding to and aligned relative to the plurality of scalpets;deploying the scalpet array from the housing into tissue at the targetsite and generating a plurality of incised skin pixels at the targetsite when deployed; retracting the scalpet array into the housing fromthe target site; inserting the plurality of extrusion pins into andclearing an interior of the plurality of scalpets.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly. The scalpetassembly includes a scalpet array and an extrusion array. The scalpetarray includes a plurality of scalpets and at least one guide plateconfigured to establish an alignment of the plurality of scalpets. Theextrusion array includes a plurality of extrusion pins corresponding toand aligned relative to the plurality of scalpets. The method includesdeploying the scalpet array from the housing into tissue at the targetsite and generating a plurality of incised skin pixels at the targetsite when deployed. The deploying includes coupling a force of a drivesystem of the scalpet assembly to the scalpet array. The method includesretracting the scalpet array into the housing from the target site. Themethod includes inserting the plurality of extrusion pins into andclearing an interior of the plurality of scalpets.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly, wherein thescalpet assembly includes a scalpet array and an extrusion array,wherein the scalpet array includes a plurality of scalpets and at leastone guide plate configured to establish an alignment of the plurality ofscalpets, wherein the extrusion array includes a plurality of extrusionpins corresponding to and aligned relative to the plurality of scalpets;deploying the scalpet array from the housing into tissue at the targetsite and generating a plurality of incised skin pixels at the targetsite when deployed, wherein the deploying includes coupling a force of adrive system of the scalpet assembly to the scalpet array; retractingthe scalpet array into the housing from the target site; inserting theplurality of extrusion pins into and clearing an interior of theplurality of scalpets.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly. The scalpetassembly includes a scalpet array and a guide plate. The scalpet arrayincludes a set of scalpets. The guide plate maintains a configuration ofthe set of scalpets. The method includes deploying the scalpet arrayfrom the housing at each target site of a plurality of target sites andgenerating incised skin pixels at each target site when deployed. Thedeploying includes coupling a force of a drive system of the scalpetassembly to the scalpet array. The method includes retracting thescalpet array into the housing from the target site.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly, wherein thescalpet assembly includes a scalpet array and a guide plate, wherein thescalpet array includes a set of scalpets, wherein the guide platemaintains a configuration of the set of scalpets; deploying the scalpetarray from the housing at each target site of a plurality of targetsites and generating incised skin pixels at each target site whendeployed, wherein the deploying includes coupling a force of a drivesystem of the scalpet assembly to the scalpet array; retracting thescalpet array into the housing from the target site.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly. The scalpetassembly includes a scalpet array and at least one guide plate. Thescalpet array includes a plurality of scalpets. At least one guide platemaintains a configuration of the plurality of scalpets. The methodincludes deploying the scalpet array from the housing into tissue at thetarget site and generating incised skin pixels at a target site whendeployed. The deploying comprises separately deploying each scalpet ofthe scalpet array from the housing in succession. The deploying includescoupling a force of a drive system of the scalpet assembly to thescalpet array. The method includes retracting the scalpet array into thehousing from the target site.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly, wherein thescalpet assembly includes a scalpet array and at least one guide plate,wherein the scalpet array includes a plurality of scalpets, wherein theat least one guide plate maintains a configuration of the plurality ofscalpets; deploying the scalpet array from the housing into tissue atthe target site and generating incised skin pixels at a target site whendeployed, wherein the deploying comprises separately deploying eachscalpet of the scalpet array from the housing in succession, wherein thedeploying includes coupling a force of a drive system of the scalpetassembly to the scalpet array; retracting the scalpet array into thehousing from the target site.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly. The scalpetassembly includes a scalpet array and at least one guide plate. Thescalpet array includes a set of scalpets. At least one guide platemaintains a configuration of the set of scalpets. The method includesdeploying the scalpet array from the housing into tissue at the targetsite and generating incised skin pixels at a target site when deployed.The deploying comprises separately deploying each scalpet of the scalpetarray from the housing in succession. The deploying includes coupling aforce of a drive system of the scalpet assembly to the scalpet array.The method includes retracting the scalpet array into the housing fromthe target site.

Embodiments described herein include a method comprising positioning ata target site a housing comprising a scalpet assembly, wherein thescalpet assembly includes a scalpet array and at least one guide plate,wherein the scalpet array includes a set of scalpets, wherein the atleast one guide plate maintains a configuration of the set of scalpets;deploying the scalpet array from the housing into tissue at the targetsite and generating incised skin pixels at a target site when deployed,wherein the deploying comprises separately deploying each scalpet of thescalpet array from the housing in succession, wherein the deployingincludes coupling a force of a drive system of the scalpet assembly tothe scalpet array; retracting the scalpet array into the housing fromthe target site.

Unless the context clearly requires otherwise, throughout thedescription, the words “comprise,” “comprising,” and the like are to beconstrued in an inclusive sense as opposed to an exclusive or exhaustivesense; that is to say, in a sense of “including, but not limited to.”Words using the singular or plural number also include the plural orsingular number respectively. Additionally, the words “herein,”“hereunder,” “above,” “below,” and words of similar import, when used inthis application, refer to this application as a whole and not to anyparticular portions of this application. When the word “or” is used inreference to a list of two or more items, that word covers all of thefollowing interpretations of the word: any of the items in the list, allof the items in the list and any combination of the items in the list.

The above description of embodiments is not intended to be exhaustive orto limit the systems and methods to the precise forms disclosed. Whilespecific embodiments of, and examples for, the medical devices andmethods are described herein for illustrative purposes, variousequivalent modifications are possible within the scope of the systemsand methods, as those skilled in the relevant art will recognize. Theteachings of the medical devices and methods provided herein can beapplied to other systems and methods, not only for the systems andmethods described above.

The elements and acts of the various embodiments described above can becombined to provide further embodiments. These and other changes can bemade to the medical devices and methods in light of the above detaileddescription.

In general, in the following claims, the terms used should not beconstrued to limit the medical devices and methods and correspondingsystems and methods to the specific embodiments disclosed in thespecification and the claims, but should be construed to include allsystems that operate under the claims. Accordingly, the medical devicesand methods and corresponding systems and methods are not limited by thedisclosure, but instead the scope is to be determined entirely by theclaims.

While certain aspects of the medical devices and methods andcorresponding systems and methods are presented below in certain claimforms, the inventors contemplate the various aspects of the medicaldevices and methods and corresponding systems and methods in any numberof claim forms. Accordingly, the inventors reserve the right to addadditional claims after filing the application to pursue such additionalclaim forms for other aspects of the medical devices and methods andcorresponding systems and methods.

1-107. (canceled)
 108. A method comprising: configuring a scalpetassembly to include a plurality of scalpets and to couple to a housing;configuring each of the plurality of scalpets to include a cylindricalshaft comprising a proximal end and a distal end, configuring theproximal end to couple to a drive assembly of the scalpet assembly, andconfiguring the distal end as a circular scalpel with a cutting surface;configuring the drive assembly to rotate the plurality of scalpets tofractionally resect tissue by circumferentially incising skin pixels;and configuring a vacuum component to evacuate the resected material viathe scalpet assembly.
 109. A method, comprising: configuring a scalpetassembly to include a substrate and a scalpet array comprising aplurality of scalpets; configuring each scalpet of the plurality ofscalpets to include a proximal end, a distal end, and a shaft includinga lumen between the proximal end and the distal end; configuring aregion of each scalpet to couple to the substrate and configuring thedistal end to include a circular cutting surface to incise skin pixels;and configuring a drive system to removably couple to a handpieceassembly and to rotate the plurality of scalpets.
 110. The method ofclaim 109, comprising configuring the drive system to include a driveshaft coupled to the plurality of scalpets.
 111. The method of claim110, comprising configuring the drive shaft to couple via the handpieceassembly to a motor configured to rotate the drive shaft.
 112. Themethod of claim 110, comprising configuring the drive system to includegears configured to be driven by the drive shaft to deliver therotational force to the scalpet array.
 113. The method of claim 112,comprising configuring each scalpet of the plurality of scalpets tocouple to a gear.
 114. The method of claim 113, comprising configuringthe drive system to cause each scalpet of the plurality of scalpets torotate around a central axis of the respective scalpet.
 115. The methodof claim 109, comprising configuring the lumen of each scalpet to passthe incised tissue from the distal end.
 116. The method of claim 115,comprising configuring the proximal end of each scalpet to pass tissuefrom the lumen.
 117. The method of claim 109, comprising configuring thecutting surface to include at least one of a beveled edge, a serratededge, and at least one sharpened point.
 118. The method of claim 109,comprising configuring a position of the plurality of scalpets to beadjustable to control a depth of insertion of the plurality of scalpetsat a resection site.
 119. The method of claim 118, comprisingconfiguring the substrate to include a plurality of guide plates and aplurality of spacers configured to control and maintain the depth ofinsertion.
 120. The method of claim 109, comprising configuring thescalpet assembly to couple to a vacuum component.
 121. The method ofclaim 120, comprising configuring a housing to include the scalpetassembly and the drive system, and to removably couple to the handpieceassembly and the vacuum component.
 122. The method of claim 121,comprising configuring the housing to couple the vacuum to the lumen ofthe plurality of scalpets to evacuate at least one of the incised skinpixels and subdermal fat from the resection site via the lumen.
 123. Themethod of claim 109, comprising an extrusion system configured toinclude a plurality of extrusion pins corresponding to the plurality ofscalpets.
 124. The method of claim 123, wherein the extrusion systemincludes an ejector component coupled to the plurality of extrusionpins, wherein the ejector component is configured to control movement ofthe plurality of extrusion pins relative to the lumen of the pluralityof scalpets.